Assistant General Manager, Quality Assurance Amneal Pharmaceuticals

12.0 - 16.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Quality Control Compliance Reviewer at Amneal, you will be responsible for ensuring cGMP compliance in the QC laboratory. Your key responsibilities include: - Reviewing the completeness of analytical documents and approving the Certificate of Analysis (CoA) for Raw materials, packaging materials, In-process, finished products, stability studies for submission, validation, and commercial batches. - Performing/reviewing investigations for Quality issues such as Out of Specification (OOS), Deviations, Incidents, Corrective and Preventive Actions (CAPAs) related to laboratory. - Ensuring implementation of CAPAs recommended in OOS, Out of Alert Limits (OOAL), Incidents, and deviations in the...

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Assistant General Manager, Quality Assurance Amneal Pharmaceuticals

12.0 - 15.0 years

0 Lacs

ahmedabad, gujarat, india

On-site

Essential Functions JOB DESCRIPTION Responsible for cGMP compliance review in QC laboratory Responsible tenure the completeness of the analytical documents and approval of CoA of Raw materials, packaging materials, In-process, finished products, stability study intended for submission, validation & commercial batches. Responsible to perform / review of the investigation for Quality issues like OOS, Deviations, Incidents, CSIR of QC laboratory Responsible to ensure the implementation of CAPAs recommended in OOS, OOAL, Incidents and deviations related laboratory. Responsible for the review of Change controls related to QC laboratory. Responsible for the review of chromatographic and non-chroma...

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