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.

Work arrangement
No