Key Responsibilities
- Review analytical raw data, laboratory records, worksheets, and test reports for accuracy and compliance.
- Review and approve RM, PM, In-Process, Finished Product, Stability, and Validation documentation.
- Manage QMS activities including Deviations, OOS, OOT, CAPA, Change Control, and Risk Assessments.
- Conduct investigations, root cause analysis, and ensure timely closure of quality events.
- Review SOPs, specifications, protocols, reports, and other controlled documents.
- Ensure compliance with GMP, cGMP, Data Integrity, and regulatory requirements.
- Monitor QMS metrics, trends, and prepare periodic quality reports.
- Coordinate with QC, QA, Production, and other departments for quality-related activities.
- Support internal audits, customer audits, and regulatory inspections.
- Ensure timely closure of review observations and maintain proper documentation.
- Participate in continuous improvement initiatives and quality system enhancements.
- Provide guidance and support to junior team members.
Pay: ₹500,000.00 - ₹650,000.00 per year
Benefits:
- Health insurance
- Leave encashment
- Provident Fund
Work Location: In person
