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2 Laboratory Incidents Jobs

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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 alig...

Posted 2 days ago

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3.0 - 7.0 years

0 Lacs

hosur, tamil nadu

On-site

The responsibilities for this role include reviewing raw and finished product specifications, ensuring good laboratory practices in the Quality Control department, reviewing audit trial records, analyzing analytical records, reviewing instrument calibration and equipment qualification documents related to QC, validating analytical methods, verifying samples, handling reserve sample room, ensuring analyst qualification, reviewing working standards, managing deviations, change control, OOT, OOS, laboratory incidents, investigations, and annual trends, coordinating CAPA implementation verification and closure, reviewing instrument and equipment preventive maintenance, monitoring and recording t...

Posted 1 month ago

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