Job Responsibilities:
- Perform in-process checks during API manufacturing
- Ensure compliance with cGMP and SOP requirements
- Monitor critical process parameters and record observations
- Verify line clearance, equipment status, and cleanliness
- Report deviations and support investigations & CAPA
- Coordinate with Production, QC, and QA teams
2 BMR Review – 04 Nos
Job Responsibilities:
- Review Batch Manufacturing / Production Records for accuracy and completeness
- Ensure adherence to approved BMRs, SOPs, and regulatory guidelines
- Check compliance with ALCOA+ data integrity principles
- Identify documentation discrepancies and ensure timely closure
- Support audits and regulatory inspections
3 Dispatch – Documentation & Reviewer – 02 Nos
Job Responsibilities:
- Review and approve dispatch-related documents (COA, packing list, invoice, labels)
- Ensure QA release of API batches prior to dispatch
- Verify compliance with customer and regulatory requirements
- Coordinate with Warehouse, QC, and Logistics teams
- Maintain dispatch records and ensure traceability
4 E&S; – Documentation & Reviewer – 02 Nos
Job Responsibilities:
- Prepare and review Setting & Safety (E&S;) documentation
- Ensure compliance with statutory and regulatory safety requirements
- Maintain SOPs, risk assessments, and safety records
- Support audits and inspections related to EHS compliance
- Coordinate with EHS and QA teams for documentation control