QMS - Executive

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 (Good 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.