Executive / Sr. Executive - Quality Assurance
2 days ago
We are seeking a highly skilled Executive / Sr. Executive Quality Assurance with 8 to 10 years of experience in API / Bulk Drug Manufacturing. The role involves overseeing laboratory incidents, OOS/OOT investigations, analytical method validations, data integrity compliance, and ensuring adherence to GMP and regulatory standards.
Key Responsibilities:
- Handle and review laboratory incidents, OOS (Out of Specification), OOT (Out of Trend), deviations, and root cause investigations.
- Review and monitor calibration schedules and records for critical analytical instruments (HPLC, GC, UV, IR, AAS, ICP-MS).
- Oversee analytical method validation, method transfers, and specification reviews in alignment with regulatory requirements.
- Provide training to QC teams on laboratory procedures, data integrity, and documentation practices.
- Conduct surprise lab audits/visits and proactively identify compliance gaps to ensure readiness for inspections.
- Ensure compliance with cGMP, ICH, and regulatory guidelines throughout QA operations.
Eligibility Criteria:
- Education: B.Sc / M.Sc in Chemistry or related field.
- Experience: Minimum 8 to 10 years in pharmaceutical Quality Assurance (API / Bulk Drug).
- Preferred Candidates: Male candidates available for immediate joining.
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