The Company
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 Description
As a QA Associate , you provide onsite 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, ready to be distributed.
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
- 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
Requirements
- MBO or BSc in Life Sciences, Pharmaceuticals, or related field
- Minimum 3 years of experience in QA or manufacturing within pharma or other regulated manufacturing industries
- Experience with batch record review and handling deviations/investigations
- Strong understanding of GMP/GDP/GCP principles
- Fluent in English
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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Catalina Gorohovschi
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