Executive / Sr. Executive - Quality Assurance Kreative Organics

8.0 - 10.0 years

5 - 10 Lacs

hyderabad

Work from Office

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 .

Posted 13 hours ago

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