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