Are you an experienced QA professional who can take independent responsibility within a sterile GMP environment? For a pharmaceutical manufacturing site, we are looking for a Senior Quality Assurance Officer. In this position, you play a key role in securing GMP compliance within a sterile production environment. The focus is on technical depth, autonomy, and experience. This is explicitly not a junior role.
Job DescriptionThe manufacturing site focuses on the production of sterile (biological) products and operates under strict GMP guidelines. Within this regulated and technically complex environment, you will fulfill a senior QA role with a clear operational focus. As Senior QA Officer, you are responsible for day‑to‑day Quality Assurance support for production. You act as a content expert for operations and as a key link towards the Qualified Person (QP). You maintain strong visibility on the shop floor and proactively drive GMP compliance, quality awareness, and sound decision‑making.
Responsibilities- Independently perform and coordinate deviation management, including root cause analyses and CAPAs
- Assess and guide change control processes
- Contribute to validation and qualification of equipment, rooms, and processes
- Review and approve procedures, work instructions, protocols, and production documentation
- Actively ensure GMP and Annex 1 compliance on the shop floor
- Align content decisions with production, QA colleagues, and the QP
- Contribute to continuous improvement of Quality processes within the site
- Minimum of a completed Bachelor's degree (preferably in Biotechnology, Biochemistry, Microbiology, or similar)
- 5+ years experience with GMP
- 3+ years of relevant experience in Quality Assurance within the pharmaceutical industry
- Proven experience with deviation management, CAPA, and change control
- Experience with validation and qualification of equipment and cleanrooms
- Independent, decisive, and strong in technical content
- Contract type: Temporary via Oxford Global Resources
- Workweek: 40 hours per week
- Duration: at least 1 year
- Salary indication: €4,200 - €6,200 gross per month, depending on experience
- Vacancy reference: 27153
€4200 - €6200 monthly