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 and Quality Risk Management
Perform assigned activities in the Quantum software system as per authorized user rights. Prepare, review, and maintain Quality Risk Management (QRM) documents.
