A leading global biotechnology organization, dedicated to developing and delivering innovative medicines to improve patient outcomes. Operating worldwide, the company combines science, technology, and quality-driven processes to ensure safe and effective clinical products.
Role DescriptionAs a Senior Associate QA, you provide on‑site Quality Assurance support within the production area. You act as a key point of contact for quality‑related matters, ensure compliance with GMP standards, and review batch documentation for products assembled, packaged, and labeled on site.
Responsibilities- Provide daily QA guidance in production areas to ensure compliance with SOPs and work instructions.
- Act as first point of contact for quality‑related questions during packaging and labeling.
- Review and approve batch production record entries prior to manufacturing activities.
- Perform in‑process and finished product checks during commercial production.
- Compile, review, and prepare batch records for QP disposition.
- Conduct GMP compliance checks and support deviation handling.
- Author or review SOPs and work instructions.
- Support GMP training activities for QA and production teams.
- MBO or BSc in Life Sciences, Pharmaceuticals, or related field.
- Minimum 3 years of experience in QA or manufacturing within pharma or medical devices.
- Experience with batch record review and handling deviations/investigations.
- Strong understanding of GMP/GDP/GCP principles.
- Fluent in English.
This is a 3‑shift position requiring full commitment.
- Week 1: Night shift (22:30 – 07:00)
- Week 2: Late shift (14:30 – 23:00)
- Week 3: Early shift (06:30 – 15:00)
- Week 4: Late shift
- Week 5: Early shift
€50000 - €70000 monthly
