Assitant Manager - Analytical QA

Job Responsibilities

• Review of Analytical Method development reports.
• Review of Analytical Method Verification and validation protocols and reports.
• Review of Specification and standard test procedure.
• Review of Analytical Test Data Sheets.
• To review stability protocols and reports.
• To coordinate with various departments for the implementation of Analytical technology transfer and review of all technology transfer documents.
• Responsible for handling and review of Quality Management system including Change controls, Deviations, Non Conformances, Incidents, investigation and Corrective and Preventive Action.
• Handling of Out of Specification (OOS), investigation and closer of OOS.
• Handling of Out of Trends (OOT), investigation and closer of OOT.
• SOPs Preparation and review.
• Review of documents viz. Specifications / STPs / GTPs / Technical Directions/Protocols/Reports.
• Issuance of formats and records to all departments like Engg, Store, QC and production etc.
• Review of contract testing laboratory documents before archival.

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