Überblick über die Statistik des Gehaltsniveaus für "GMP Pharmacist in Deutschland"

Speculative application  Skills: Acne, Actinic Keratosis, Acute Myelogenous Leukemia (AML), AIDS, Allergic Rhinitis, Allergy, Alzheimer's, Anaesthetics, Antibiotics, Anti-infectives, Anxiety, arrhythmia, Asthma, Autoimmune diseases, Autoimmune Disorder, Bacterial Vaginosis, Breast Cancer, Cardiology, Cardiovascular, chemotherapy, Chronic Lymphocytic Leukaemia, Chronic Myeloid Leukemia, Chronic Obstructive Pulmonary Disease, Clinical Pathology, CLL, Congestive Heart Failure, COPD, Cosmetics, Cystic Fibrosis, Dementia, Dentistry, Depression, Dermatology, Diabetes, Diagnostics, Dietetics, Endocrine, Endocrinology, Epilepsy, Family Medicine, Fibromyalgia, Gastroenterology, gastrointestinal, Genetic Diseases, GI, Glioblastoma Multiforme (GBM), Gynaecologic, Gynaecology, Gynecology, Haematology, Haemophilia, Heart Disease, Hematology, Hemopure Anemia, Hepatitis, Hepatology, HIV, Hodgkin's disease, Hypertension, IBD, Immunogenicity, Immunopharmacology, Infections, Infectious Diseases, Influenza, Internal Medicine, Joint Replacement, Lymphoma, Mantle Cell Lymphoma, Melanoma, Menopause, Metabolic, Migraine, Multiple Sclerosis, Musculoskeletal, Myelodysplastic Syndrome, Neonatology, Nephrology, Neurodegenerative disorders, Neurology, Neuroscience, NEUROSURGERY, non small cell lung cancer, Non-Hodgkin Lymphoma, nutraceuticals, Nutrition, OA, Obstetrics, Oncology, Ophthalmology, Oral Health, Orphan Diseases, Orphan drug, Orthobiologic Bone graft, Orthopedic Surgery, Orthopedics, Osteoarthritis, Otitis Externa, Otolaryngology, Ovarian Cancer, Paediatric, Pain, Painful Diabetic Neuropathy, Parkinson’s Disease, Physiology, Podiatry, Post-Menopausal Osteoporosis, Primary Immune Deficiency, Primary Sjogren’s Syndrome, Prostate cancer, Prostatic hyperplasia, Psychiatry, Psychology, Pulmonary, Pulmonology, RA, Rare Disease, Respiratory, retinopathy, Rheumatoid Arthritis, Rheumatology, Rhinitis, Rosacea, Schizophrenia, Seasonal Allergic Rhinitis, Severe Hemophilia, Skin Melanoma, Sleep Disorder, Sleep Medicine, Small Lymphocytic Lymphoma, Small Molecule, Smoking Cessation, Solid Tumors, surgery, Systemic Lupus Erythematosus, Systemic Sclerosis, Tissue Ablation, Transplant, Trauma, Traumatology, Type 2 Diabetes Mellitus, Urology, Vaccine, Vaccines, Vascular Diseases, Weight Loss, Women’s Health, Administrative Assistant, Agile Project Manager, Artwork Coordinator, Associate Director Clinical Operations, Associate Project Manager, Auditor, Biomedical Engineer, Biometrics Manager, Biosample Operations Manager, Biostatistician, Biostatistics Associate Director, Brand Team Lead, Business Administration Associate, Business Administration Manager, Business Analyst, Business Development Associate, Business Development Director, Business Development Manager, CEO, Change Manager, Chemical Project Manager, Chemist, Chemistry, Manufacturing & Control Lead (CMC), Chief Financial Officer, Chief Operating Officer, Chief Technical Officer, Clinical Data Associate, Clinical Data Manager, Clinical Data Specialist, Clinical Development Manager, Clinical Engineer, Clinical Lead, Clinical Operations Director, Clinical Operations Manager, Clinical Pharmacologist, Clinical Programmer, Clinical Project Manager, Clinical Research Associate, Clinical Research Director, Clinical Research Manager, Clinical Research Physician, Clinical Research Specialist, Clinical Study Coordinator, Clinical Study Manager, Clinical Supply Coordinator, Clinical Supply Manager, Clinical Trial Assistant, Clinical Trial Educator, Clinical Trial Manager, Clinical Trial Specialist, CMC Manager, Commercial Manager, Communication Manager, Compliance Associate, Compliance Manager, Computer System Validation Specialist, Contract Associate, Contracts Manager, Country Manager, Customer Service Associate, Data Analyst, Data Analytics Assistant, Data Engineer, Data Management Associate Director, Data Management, Manager, Database Programmer_Designer, Demand Planner, Demand Manager, Developer, Diagnostic Specialist, Director of Contracts & Licensing, Dispensary Assistant, Document Specialist, Drug Safety Associate, Drug Safety Director, Drug Safety Manager, Early Access Project Manager, EHS associate, Electronic Data Capture Manager, Electrophysiologist, Employer Engagement Manager, Engineer (out of industry), Epidemiologist, Exploratory Project Manager, Feasibility Manager, Freelance, FSP Clinical Manager, Global Clinical Data Manager, Graduate, Head of Clinical Data Management, Head of Clinical Operations, Head of Risk Management, Health Economist, Health Information Associate, Healthcare Compliance Manager, HR Associate, HR Manager, Imaging Operations Lead, Inhouse Clinical Research Associate, Intern, Investigator, IT Project Manager, Junior Clinical Data Manager, Junior Clinical Research Associate, Junior Pharmacovigilance officer, Junior SAS Programmer, KOL, Laboratory Assistant, Laboratory Manager, Legal Advisor, Licensing Coordinator, Logistics Associate, Logistics Manager, Logistics Supervisor, Manufacturing Manager, Manuscript Editor, Market Access Manager, Market Access Specialist, Market Insights Specialist, Market Research Associate, Marketing Associate, Material Coordinator, Medical Advisor, Medical Assistant, Medical Devices Project Manager, Medical Director, Medical Information Assistant, Medical Information Associate, Medical Information Manager, Medical Manager, Medical Monitor, medical publisher, Medical Representative, Medical Research Associate, Medical Reviewer, Medical Science Liaison, Medical Technologist, Medical Writer, Medico-economic affairs, Meeting Coordinator, MHRA Pharmacovigilance Inspector, Microbiologist, Occupational Therapist, Office Manager, Ophthalmologist, Packaging Associate, Packaging Coordinator, Patient Recruitment Coordinator, Payroll Specialist, Pharmaceutical Physician, Pharmacist, Pharmacokineticist, Pharmacology Director, Pharmacovigilance Manager, Pharmacovigilance Officer, Physiotherapist, Planning analyst, Policy Officer, Post Doctoral Researcher, Preclinical Project Manager, Principal Biostatistician, Principal Scientist, Privacy Officer, Product manager, Production Manager, Production Specialist, Program Development Manager, Programmer Analyst, Programming Associate Director, Project Assistant, Project Manager (other industry), Proposal Developer, Psychiatrist, Psychologist, Publications Manager, QPPV, Qualified Person, Quality Assurance Assistant, Quality Assurance Complaint Specialist, Quality Assurance Director, Quality Assurance Manager, Quality Assurance Specialist, Quality Control Associate, Quality Control Manager, Quality Control Specialist, Quality Engineer, Quality Manager, Quality Specialist, R&D Manager, R&D Project Manager, Record Specialist, Recruitment & Screening Co-ordinator, Registration Specialist, Regulatory Affairs Administrator, Regulatory Affairs Associate, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs VP, Regulatory Documentation Scientist, Regulatory Information Specialist, Regulatory labelling specialist, Regulatory Program Manager, Regulatory Site Activation Manager, Remote Site Monitor, Senior, Research Coordinator, Research Funding Manager, Research Team Manager, Resources Manager, Respiratory Physiotherapist, Sales Manager, Sales Rep, Sample Manager, SAS Programmer, Scientific Advisor, Scientific Affairs Associate, Scientist, Senior Associate Supply Chain (GMP), Senior Biostatistician, Senior Clinical Lead, Senior Clinical Research Associate, Senior Clinical Supply Chain Associate, Senior Clinical Team Manager, Senior Clinical Trial Manager, Senior Epidemiologist, Senior Medical Affairs Officer, Senior Nutrition Scientist, Senior Regulatory Affairs Manager, Senior Scientist, Site Engagement Manager, Site Visit Report Reviewer, SOFTWARE DEVELOPER, Software Engineer, Start Up Director, Start-up Manager, Start-Up Specialist, Strategy Lead, Study Authorisation Associate, Study Delivery Operational Specialist, Submissions Manager, Supply Chain Coordinator, Supply Chain Manager, Supply Chain Planner, Surgical Technician, Systems Administrator, Technical Project Leader, Technical Services Specialist, Training Associate, Training Manager, Translator, Validation Engineer, Vendor Manager, Veterinary Nurse, Warehouse Associate, Warehousing & Distribution Leader, BSc, CQA, GMC, MBA, MBChB, MD, MPhil, MRCPsych, MSc, No CRA Certificate, PGDip, Ph.D Statistics, Pharm D, PhD, PRINCE2, Registered Nurse, SAP, Six Sigma, SolTRAQs, Veterinary, 3PL, ADaM, Administration, Adverse Event management, Advocacy plans, Agile, AKTA, Analytical SEC, Animal Health, APICS, Applicant Tracking System Management, APS, ARISg, auditing, Batch release, Batch Review, BHV, Bioequivalence, Bioinformatics, Biologic, Biomarkers, biometrics, Biosamples, Biosimilars, Biostatistics, Biotech, Black Belt, Business Development, C++, Candidate Attraction, CAPA, CDISC, Cell Biology, Cell stem-based therapy, CER, Chemstations, Client communication, Clinical, Clinical Affairs, Clinical Data Management, Clinical Programming, Clinical Research Organisation, Clinical Trial Applications, clinical trials, close out visits, CMC, CMO, Commercialisation, Compassionate Use, Competent Authorities, Computer Systems Validation, Contract, CPIM, CRF Design, CRO, CSR, Data Analysis, data entry, Data Science, Data Warehouse, database design, Datalabs, DHPC, Distribution, Distribution Planning, DMC, Document Management, Downstream, Drug destruction, Drug Development, Drug Safety, DSUR, E2E, Early Access, Early Phase, EC Submissions, ECG, eCRF, EDC, electronic data capture, ELISA, Epidemiology, ePRO, ERP, eTMF, e-TMF, EU Legislation, Eudravigilance, European Federation of Pharmaceutical Industries, Export Management, FDA Audits, Feasibility, Finance, Forecast, FPLC, GCP, GDP, Gene Therapy, Global, Global Regulatory Affairs, GLP, GMP, Government Affairs, GS1 standards, Health Economics, Healthcare, Healthcare Compliance, Healthy Volunteers, Home-based, HPLC, IATA, ICF, ICH-GCP, Imaging, Immunology, IMP, IMPACT, IMPD, Import Management, IND, InForm, Informatics, International, Interviewing, Inventory Management, Investigator Payments, in-vitro, in-vivo, IRB Submissions, IRT, ISO 13485, ISO 13485:2003, ISO 14971, ISO 9001, ISO13485, IVRS, Java, Lab, Labelling, Laboratory, LEAN, Line Management, Logistics, MA-CC, Manufacturing, MAPP, Market Access, Market Insights, Market Intelligence, Market Research, Marketing, Marketing authorizations, Materiovigilance, MedDRA, Medical Affairs, Medical Communication, Medical Devices, Medical Information, Medical Writing, Medidata Rave, Monitoring, Monitoring Visit, MS Office, MS Project, My Trials, NMR, Office-based, Oracle, Outcomes Research, Outsourcing, Packaging, Paediatrics, Patient Outcomes, Permanent, PET scans, Pharma, Pharmaceutical, Pharmacodynamics, Pharmacoeconomics, Pharmacoepidemiology, Pharmacokinetic, Pharmacokinetics, Pharmacology, Pharmacovigilance, Pharmacy, Phase I, pipetting, PMP, Policy, Post Marketing, Postdoctoral research, Post-marketing, Preclinical, Pricing & Reimbursement, Pricing and Reimbursement, PROC, Process Excellence, Procurement, Product Management, Project Leadership, Project Management, PromoMats, Protein Characterisation, protocol development, Protocol writing, PSURs, Public Affairs, publishing, Purchasing, QP, Qualification Visit, Quality Assurance, Quality Control, Quality Management, Quality Management System, Radiology, Randomisation, Randomization, Rave, Reactovigilance, Real World Evidence, Recruitment, Regional Monitoring, Regulatory, Regulatory Operations, Regulatory submissions, Regulatory Systems Management, remote monitoring, RFI, Risk Management, risk-based monitoring, RMA, RMP, SAE, SAE reporting, Sales Inventory, Sample size estimation, Samples, SAS, Scrum, SDS-PAGE, SDTM, Serialisation, Shipments, shipping, Simoa, Site contracts, Site Engagement, site payments, SOX, SPC- CCDS, Spectroscopy, S-Plus, SPSS, SQL, Start-up activities, statistical analysis, Statistics, Study Management, Study Medication Labelling, Sunshine Act, Supplier Qualification, Supply Chain Distribution, Supply Chain Management, Supply Chain Planning, Supply Planning, SUSAR, SUSARs, TMF, Toxicogenomics, Toxicology, Trackwise, Training, Transport Management, Unicorn Purification System, UPLC, Upstream, UV-Vis Spectroscopy, validation, Veeva, Vendor Management, Venipuncture, VISIO, Western Blot, ZINC, Bratislava, Slovakia, Afrikaans, Argentinian, Armenian, Belgian, Bosnian, Bulgarian, Cambodia, Cantonese, Catalonian, Chinese, Croatian, Czech, Danish, Dutch, English, Flemish, French, Greek, Gujarati, Hebrew, Hungarian, Italian, Japanese, Korean, Latvian, Lithuanian, Luxembourgish, Macedonian, Malayalam, Mandarin, Montenegrin, Norwegian, Persian, Punjabi, Romanian, Russian, Serbian, Slovak, Slovene, Slovenian, Spanish, Swedish, Thai, Turkish, UkrainianLocation: GloballyShare: 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We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred

We have an exciting opportunity for an Associate Qualified Person. You will provide direction to PLD, PM&D and LQM which includes mentoring and training of GxP relevant topics and the supervision of Quality Management projects.This role is based in at our Schoenefeld Depot in Berlin. Open to consider international candidates that possess the right to work in Germany. You will serve as a quality consultant to designated operational group(s) and will be responsible for: Identification of process improvement opportunities. Process authoring and review, support for process re-engineering Provide GxP and process expertise to designated operational group(s) Support for identification, management, and prevention of quality issues and assist with the collection and reporting of quality metrics as assigned Key responsibilities also include that:Each batch of investigational medicinal products manufactured in or imported into the Union complies with the requirements set out in Article 63 of REGULATION (EU) No 536/2014 and Article 13.3 of Directive 2001/20/EC and your role is to certify that those requirements are fulfilled.Medicinal products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP.Product imported from 3rd countries into the EU was manufactured and tested according to EU-GMP. The Qualified Person has to personally convince himself by audit that the IMP was produced according to EU-GMP and the Clinical Trial application (IMPD).Critical quality attributes of each IMP are understood and that the QP has sufficient knowledge about each IMP to perform the Batch Certification.Batch certification is recorded in a register or equivalent document.Batch certification is only performed after confirmation that each production batch was manufactured and tested according to EU-GMP.Delegation of any QP-tasks is performed only to another Qualified Person(s).Release of Investigational Medicinal Products (IMP) is performed according to clinical trial regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice.Guidance on technical and regulatory requirements for the conduct of clinical trial is given, as well as advice on GxP-issues.A Quality Management System is in place that safeguards that correct procedures in the process for assembly and supply of study medication (investigational medicinal products) are followed.A Quality Management System is in place that safeguards that Quality Control procedures are in place and followed.Internal and external audits are assisted including supplier qualification audits (e.g. supplier providing starting materials for production activities).Direct reports are adequately advised, instructed, and managed in accordance with the internal processes relevant for a Parexel line manager.Acts as a backup Head of Quality Control EUDC in case of absence (holidays, sick leaves, etc.) of one of the main HQCs EUDC.Skills, Knowledge and ExperienceExcellent knowledge about EU and global GMP, GCP and GDP regulationsExperience with EU QP-Batch Certification and Release procedure of IMPExcellent bio-pharmaceutical knowledge and product understanding of current IMPs and IMPs in the development pipelines (e.g. Cell and Gene Therapy Products)Experience with Import & Export of pharmaceutical productsExperience in Quality Control, Quality Assurance, Quality Systems, Quality Compliance and Quality Improvement requiredGMP / GDP auditing experienceAuthority Inspection experienceProject management and leadership abilities: Six Sigma LEAN Green Belt or aboveExperience in Quality Control and Quality Assurance requiredAbility to think and work globally and be culturally awareAbility to handle several highly complex projects/tasks simultaneously, potentially spanning different Strategic Business UnitsAbility to act as the main quality interface with clientsCustomer-focused in defining and establishing prioritiesAbility to work independently, take initiative, and have a flexible approach with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmAbility to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organizationHighly IT literate: Microsoft based applicationsAbility to travel as needed for the positionLanguage Skills Must have fluent speaking, written & verbal skills in English, German preferred.EducationFulfilment of qualification as per §15 AMG (as interpreted by local authority LAVG in Brandenburg, Germany):Registered PharmacistPractical experience over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative and quantitative analysis of medicinal productsPhD degree preferred