QA Manager – GMP.
QA Manager – GMP
€5000 - €5500 per month|
Join a growing Pharmaceutical Company in Nijmegen
Title: QA Manager - GMP Lead
Reporting To: Director - QA/GMP
Industry: Life Sciences - Pharmaceuticals
Salary: €5,000-€5,500/month plus bonus, vacation pay and package
At Darwin Recruitment, we are proud to be partnered with a leading player in the Pharmaceutical industry. They are developing a range of products for the market, with a number of products in development. The products develop range from disease medication, pain relief and cold/flu remedies.
Working in the QA team as the QA GMP Lead, where you will play a pivotal role in supporting and guiding our clients CMC team on all quality-related matters concerning drug substance, drug product, and packaging activities. Reporting to the Director GMP, you will oversee documentation and procedures related to production, quality control, and batch certification of investigational medicinal products.
Your responsibilities include but not limited to the following:
- Oversee QA operations across the company's CMC supplier network.
- Negotiate and manage quality technical agreements for cGMP manufacturing projects.
- Review and approve protocols, instructions, specifications, and records, including batch records, stability, and validation protocols and reports.
- Lead and oversee suppliers' qualification and validation activities.
- Review, approve, and track change control activities, ensuring regulatory compliance.
- Bachelors degree in a relevant field
- 10+ years of experience in the pharmaceutical industry, with at least 3 years in quality assurance in similar roles.
- Extensive experience in QA aspects of drug substance and/or drug product development activities, with a comprehensive understanding of the pharmaceutical development process.
- Deep knowledge of quality systems, cGMP, regulations, and guidelines relating to CMC.
- Experience in investigational medicinal product packaging and release activities.
- Preferred qualifications include trained GMP (lead) auditor, Qualified Person (QP)/Responsible Person (RP in CH) certification, FDA expertise, and sterile dosage form experience.
Please apply or email james.allen@darwinrecruitment for more information.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.James Allen
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