Pharma API Quality Assurance Specialist
1 month ago
Job Overview
At Infinitalent Consulting (P) Ltd, we are seeking a highly skilled Quality Engineer for Pharmaceutical API Production. This role involves handling quality events in the production department, including Change Control, Deviation, OOS, OOT, CAPA, and investigation, as well as preparing equipment performance qualification protocols and reports.
Responsibilities
- Handling quality events, including Change Control, Deviation, OOS, OOT, CAPA, and investigation
- Preparing equipment performance qualification protocols and reports
- Providing data to QA for process validation protocols and reports
- Preparing batch manufacturing records, master formula records, and standard operating procedures related to production
- Coordinating document review and approval for production-related documents
- Training production staff on SOPs, BMRs, CAPA, and documentation practices
- Collaborating with cross-functional teams for data collection and document review
- Supporting internal and external audits and inspections
- Maintaining production documentation storage, retrieval, and archival
- Reviewing batch manufacturing records and batch packing records
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