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2 Audit Trial Jobs

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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 temperature and humidity in the laboratory area, and managing document control. The ideal candidate should possess skills in audit trial, OOT, deviation handling, OOS, backup and restoration data management, sample handling, instrument maintenance, quality assurance, instrument calibration, laboratory practice, laboratory incidents management, change control, method edit forms, working standards review, analytical records analysis, quality control, document management, equipment qualification, stability protocols, analyst qualification, analytical method validation, CAPA implementation, and temperature monitoring.,

Posted 3 days ago

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4.0 - 8.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for handling production equipment including vial washing & Depyrogenation tunnel, Autoclave, Manufacturing, Steam air sterilizer, Laundry area, Vial coding (Domino), and external vial washing. Additionally, you will be in charge of the requalification/qualification of equipment such as autoclave, vial washing, and tunnel. Your duties will also include managing the auto CIP & SIP process of manufacturing tanks, as well as having knowledge about audit trails and data backup. Familiarity with computer systems like eBMR, PLC, and SCADA will be essential for this role. Furthermore, you should possess knowledge about change control, regulatory affairs, corrective and preventive actions (CAPA), and environment, health, and safety (EHS) activities. The ideal candidate will have a Bachelor's or Master's degree in Pharmacy, along with 4 to 8 years of experience in the field. Previous experience at Zydus for 12 to 24 months is preferred. This position is based in the Production Department at Zydus Pfizer in Ahmedabad.,

Posted 4 days ago

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