工作内容
Quality Assurance / Quality Management• Draft, review, and revise local SOPs, work instructions, and manuals for QA/QM activities in accordance with global SOPs and local regulations.• Maintain quality records in compliance with local/global SOPs, Good Distribution Practice (GDP), and other relevant guidelines.• Maintain oversight of the Document Management System (DMS), ensuring proper version control and document archival.Training & Quality Culture• Perform the role of Training Administrator, ensuring the training system remains compliant, up to date, and aligned with regulatory and global QA requirements.• Manage trainings via the e learning management system.• Conduct GDP refresher trainings and onboarding sessions for internal teams.Quality System Management• Initiate, assess, coordinate, and close change controls.• Manage deviations, product complaints, and returned goods, ensuring timely investigation, communication, and closure.• Track and manage Corrective & Preventive Actions (CAPA) to ensure timely and effective implementation.• Coordinate Product Quality Reviews (PQR) and collaborate with regional/global teams for data consolidation.• Lead the annual management review on quality objectives.Regulatory & Compliance• Support local GDP inspections by health authorities and conduct internal GDP self inspections to ensure compliance with regulatory and quality system requirements.• Ensure quality compliance for product imports, redressing activities, and release to local markets.• Manage mock recall exercises to ensure readiness and compliance.Vendor / Outsourced Activities Management• Manage outsourced activities to ensure vendors meet local and global quality standards.• Participate in qualification and periodic requalification of vendors.• Track vendor performance metrics and follow up on quality issues or improvement actions.• Support preparation and execution of vendor audits and ensure timely closure of audit findings.Cross Functional & Regional Collaboration• Collaborate with cross functional teams (Supply Chain, Commercial, Regulatory, etc.) to ensure quality compliance in distribution and operational activities.• Support regional/global quality initiatives and system implementation.
