Executive, Quality Assurance-Quality Management System (QMS)

Key Responsibilities

• Investigation Management
• Conduct investigations related to Market Complaints, Deviations, Change Controls, Incidents, Laboratory Incidents, CAPA (Corrective and Preventive Actions), Returned Goods, and Product Recalls.
• Quality Management System (QMS) Documentation
• Supervise issuance, distribution, retrieval, and destruction of all QMS documents in accordance with company procedures.
• cGMP Compliance
• Ensure effective implementation and adherence to current Good Manufacturing Practices (cGMP) at the manufacturing site.
• Documentation Support
• Assist in preparation, review, and maintenance of Quality Assurance documentation.
• Audit Handling
• Coordinate and support internal and external quality audits.
• Prepare and review compliance reports following audits.
• Quality System Documentation
• Prepare and maintain key quality documents including:
• Self-Inspection Plan
• Site Master File (SMF)
• Validation Master Plan (VMP)
• Quality Manual
• Software System Operations
• Perform assigned activities in the Quantum software system as per authorized user rights.
• Quality Risk Management
• Prepare, review, and maintain Quality Risk Management (QRM) documents.