Job Description
About Client: Client is among the Top 10 Pharmaceutical API Manufacturers in India, cater to both domestic and international markets with a diverse portfolio of Active Pharmaceutical Ingredients (APIs).
Roles And Responsibilities:
- Prepare, review, and maintain QA documents, including Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, SOPs, COAs, and audit reports.
- Manage quality system records: issuance, numbering, storage, and control of BPRs, analytical records, deviations, CAPA, OOS/OOT, change controls, and risk assessments.
- Perform IPQA activities
- Review and investigate laboratory incidents, deviations, market complaints, CAPA, and non-conformities.
- Ensure compliance with GMP in manufacturing and GLP in laboratory operations.
- Conduct internal audits, vendor audits, and servi...
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