Quality Assurance Lead
vor 1 Monat
GULP – experts united is seeking a Quality Assurance Manager for a key partner in the pharmaceutical sector. If you value a secure and equitable salary alongside meaningful work and a long-term career path, we invite you to consider this opportunity. Your satisfaction is our priority.
What We Offer
- Competitive salary package including holiday and Christmas bonuses
- Coverage for travel expenses
- Up to 30 days of annual leave
- Opportunities for professional development
- Supportive corporate environment
Key Responsibilities
- Execute quality assurance operations, including the evaluation of manufacturing batch records and release documentation for drug products and substances
- Engage in escalation task force meetings
- Assess batch records and authorize BoM related to biological and parenteral products
- Prepare necessary documentation
- Conduct tracking and trending analysis/KPIs
- Perform site visits to CMO for batch record reviews
- Assist with inspections and inquiries from regulatory bodies
- Review and endorse changes and reports (e.g., stability, qualification, validation)
Candidate Profile
- Master’s degree in (bio)chemistry, pharmacy, biotechnology, or a related field
- Relevant experience in quality assurance, quality control, or validation within the pharmaceutical or similar industries
- Familiarity with GMP/QA and experience in the production of bulk materials, intermediates, and final products
- Proficient in MS Office applications
- Fluent in both written and spoken German and English
- Ability to work independently, collaboratively, and communicate effectively
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