QMS Management

- Manage and maintain site Quality Management System procedures.
- Ensure timely processing and closure of Deviations, Incidents, investigations, CAPAs, Change Controls, and Risk Assessments.
- Review trend analysis of quality events and identify improvement opportunities.

CAPA Governance
- Track CAPA implementation and effectiveness verification.
- Ensure timely closure of corrective and preventive actions.
- Conduct periodic CAPA review meetings with stakeholders.

Change Control Management
- Review and coordinate change control proposals.
- Assess quality and regulatory impact of proposed changes.
- Monitor implementation and closure timelines.

Documentation & Compliance
- Review SOPs, protocols, reports, and quality documents.




- Ensure compliance with GDP (Valuable Documentation Practices).
- Maintain QMS records in electronic systems.

Training & Awareness
- Conduct QMS awareness and GMP training programs.
- Support employees in understanding quality systems requirements

Investigation Management
- Facilitate investigation of deviations, incidents, Market complaints, OOS, and OOT cases.
- Ensure root cause analysis using appropriate tools.
- Support closure and effectiveness verification of action plans.

📌 QMS - Executive (Daman)
🏢 Alkem Laboratories
📍 Daman