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 Description
The 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
Profile
- 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
Terms of Employment
- 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
