Job Title: QA Expert
Salary: up to 83650€ per year
Contract Type: Direct and Permanent
Work Model: Full-Time 40h, Onsite
Location: Amsterdam, North Holland, Netherlands
Look no further!
Join one of the Largest Biotechnology and Pharmaceutical Contract Manufacturing companies in the world as a QA Expert, at their state of the art Manufacturing Facility in Amsterdam.
Role Summary:
As a Quality Assurance Expert, you’ll actively participate in project teams as the Quality Assurance representative, offering guidance on quality oversight and ensuring compliance with current legislation and GMP guidelines.
As such, this position is perfect for someone passionate about maintaining the highest quality standards in a dynamic environment.
Offer and Conditions:
- Salary: up to 83650€ per year
- Contract: Direct and Permanent with the company
- Location: Amsterdam Manufacturing Facility
- Vacation: 30 days of vacation
- Benefits: holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan
- Career growth and development opportunities: Internal growth paths, support for professional development and training
Key Responsibilities:
Your main responsibilities include reviewing and approving lot packages, batch documentation, and deviations, providing essential insights to support the Qualified Person in the final batch disposition.
You will also review and approve quality records, contributing to the effectiveness of the Quality Management Systems.
In general, this will include:
- Review and approval of GMP documents and master batch records;
- Review and approval of batch manufacturing and QC testing records;
- Batch release preparation;
- Handling and assessment of deviations and change controls;
- Participation in project teams as QA project lead and contact person for clients;
- Execution of internal audits according to audit plan and support during external audits (clients and governmental bodies);
- Coordination and maintenance of quality management systems;
- Training of employees with regards to GMP matters.
Required Qualifications and Skills:
- At least a Bachelor degree in: Analytical Chemistry, Biomolecular Sciences, (Micro)Biology, Biotechnology, Biochemistry, Pharmacy, Pharmaceutical Sciences, or similar Life Science related topics;
- 5 years of QA experience in the pharmaceutical industry;
- Ability to work with tight deadlines and handle multiple tasks;
- Computer fluency in MS Office, e.g. Word, Excel, PowerPoint.
- Knowledge of Veeva and SAP is a plus;
- Experience with FDA compliance is a plus;
- Excellent verbal and written communication skills
- Language: English is an absolute must have
- Language: Dutch is a nice to have, not mandatory
Ready to Apply? Let's talk!
Submit your CV by clicking ‘Easy Apply’ or reach out to:
Sari Steenhauer, Team Lead Life Sciences at Grafton Recruitment Netherlands
📞 0633137746
Keywords: Good Manufacturing Practice (GMP), GxP, Good Laboratory Practice (GLP), Quality System, FDA GMP, cGMP practices, Change Control, Validation (Drug Manufacture), Corrective and Preventive Action (CAPA), Standard Operating Procedure (SOP), Deviation Management, U.S. Food and Drug Administration (FDA), Cleaning Validation, Process Validation, Quality Assurance, Laboratory Information Management System (LIMS), QA Automation, Pharmaceuticals, Software Validation, Biotechnology, Computer System Validation, Verification and Validation (V&V), Quality Auditing, SOP Development, Analytical Method Validation, Assay Development, Analytical Techniques, High-Performance Liquid Chromatography (HPLC), Molecular Biology, Biochemistry, Regulatory Requirements, Regulatory Submissions, Good Clinical Practice (GCP), Good Distribution Practice (GDP), ISO Standards, TrackWise, Cell Culture, International Standards, Batch Records, Microbiology, Analytical Chemistry, Equipment Qualification, Drug Discovery, Chemistry, External Manufacturing, Pharmaceutics, Hazard Analysis and Critical Control Points (HACCP), SOP Authoring, ISO 13485, ELISA, Real-Time Polymerase Chain Reaction (qPCR), ISO 9001, Supplier Quality Management, Structured Authoring, Data Quality, QA Engineering, Cell Biology, Polymerase Chain Reaction (PCR), Quality Improvement, Flow Cytometry, Gas Chromatography, Laboratory Equipment, Purification, Clinical Pathology, SDS-PAGE, Western Blotting, Immunization, Cell Therapy, Immunology, U.S. Pharmacopeia (USP), Method Development, Laboratory Medicine, Protein Chemistry, Laboratory Safety, Cancer Research, Reverse Transcription Polymerase Chain Reaction (RT-PCR), Genetics, Quality Control, Bioinformatics, Technology Transfer, DNA, Systems Improvement, Batch Processing, Management Systems, Laboratory Techniques, Biopharmaceuticals, Micro Focus Quality Center, Contract Manufacturing, Mass Spectrometry, Antibodies, Chromatography, Data Validation, Gel Electrophoresis, Food Microbiology, Food Science, Supplier Development, Root Cause Analysis, Pharmaceutical Companies, Pharmaceutical Industry, Data Analysis, Teamwork, Oral Communication, Microsoft Office, Team Building, Compliance Management, English, Veeva Vault, Cross-functional Team Leadership, Creativity Skills, Pharmacovigilance, PowerPoint, Communication, Microsoft Excel, Project Management, Pharmacy, Data Integrity, HTML, Microsoft Word, Corrective Actions, Research Skills, Leadership, IBM SPSS, Auditing, Issue Management, Lentivirus, Environmental Science, Lifesciences, Life Sciences, Laboratory, Water, Ecology, Aquatic Ecology, Certified Lead Auditor, Quality Systems, Documentum, Customer Service, Time Management, Laboratory Skills, Environmental Monitoring, SAP, Internal Audits, Documentation, Factory, Kwaliteitssysteem, Batchreview, ISO 9000, Quality Management Environmental Management, Environmental Management Systems, Sustainability, Document Review, Sustainability Management, GRI, ISO 14001, Kwaliteitsborging, Pipetting
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- Posted
- Dec 12, 2024
- Type
- Full-time
- Level
- Not Applicable
- Location
- Amsterdam Area
- Company
- Grafton Recruitment
Industries
Categories
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