Job Summary: Maintain and coordinate QMS documentation and compliance activities for the Bioproduction Unit, supporting consistent adherence to approved procedures and quality standards.

Key Responsibilities

- Maintain controlled documents, SOPs, formats, registers, specifications and records as per the document-control procedure.

- Coordinate document preparation, review, approval, issue, revision, retrieval and archival.

- Track deviations, non-conformances, corrective and preventive actions (CAPA), change controls and other QMS actions through closure.

- Coordinate internal audits, external/customer audits and inspection readiness; track observations and follow-up actions.

- Monitor training records and ensure employees receive required training on relevant SOPs and procedures.

- Support investigation of quality issues and compile data for trend analysis and periodic quality reviews.

- Check documentation for completeness, traceability, legibility and timely closure; escalate gaps to the reporting manager.

- Coordinate with Production, Quality Control, Maintenance and other teams to promote QMS awareness and continual improvement.

📌 QMS Executive Biounit (Coimbatore)
🏢 T Stanes
📍 Coimbatore