Senior QA Manager Pharmaceutical Manufacturing
2 weeks ago
Serving as the primary point of contact for all quality-related activities with external suppliers is a key responsibility of this role. Ensuring compliance with current GMP & GDP regulations, Sobi's Quality System, and relevant technical agreements are also critical tasks.
- Implement and maintain quality risk assessments and KPIs to drive continuous improvement.
- Lead quality initiatives and act as a quality representative in projects to ensure seamless collaboration across functions.
- Manage quality issues, audits, and change requests effectively to minimize disruptions and maximize efficiency.
Key Qualifications:
- Degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including relevant courses in inorganic, organic, analytical, physical and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology and toxicology, Microbiology and Pharmacognosy (QP requirements).
- More than 10 years of experience within pharmaceutical, biotech product; more than 5 years experience in QA operation or external quality including supplier quality management (GMP, GDP).
- In-depth understanding of GMP requirements of FDA; EMEA or other Health Authorities.
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