Location: [Insert Location]
Experience: 5 – 8 Years
Education: M.Sc. (Life Sciences / Biotechnology / Chemistry or related discipline)
Role Summary
We are seeking an experienced Associate Manager – Quality Systems to oversee global quality standards in biologics manufacturing. The role involves ensuring data integrity, documentation compliance, quality investigations, environmental monitoring, and supporting regulatory adherence. The ideal candidate should have a strong background in cGMP, GDP, and quality systems with hands-on experience in reviewing analytical data, managing incidents, and driving quality excellence.
Key Responsibilities
- 1. Quality System Oversight :Establish and maintain global quality system standards for biologics manufacturing.
- 2. Documentation Practices :Ensure adherence to Good Documentation Practices (GDP) during review, approval, and closure of records.
- 3. Data Review & Integrity : Review batch analytical data for accuracy, completeness, and authenticity.
- Environmental Monitoring & Testing : Analyze trends in environmental monitoring, water testing, stability studies, and laboratory incidents.
- 5. Investigations & Incident Management : Participate in investigations of OOS (Out of Specification), OOT (Out of Trend), OOL (Out of Limit), deviations, and incidents.
Educational Qualifications & Experience
- Education: M.Sc. in Life Sciences / Biotechnology / Chemistry (or related field).
- Experience: 5 – 8 years in Quality Assurance / Quality Systems within a regulated biologics or pharmaceutical manufacturing environment.