Develop, update, review/approve related procedures/QMS documentation and reports in term of compliance with regulatory/cGXP requirements and control the periodic review, distribution, access and storage of documentation to ensure proper version control.
Follow up of daily In process activities, conduct regular audits/inspection to ensure compliance/maintaining cGXP requirements in the respective areas.
Monitor, Review and approve change control processes, related assessment and actions to ensure all changes to products, processes and systems are properly evaluated, approved and implemented effectively.
Overview and review/approve of non-conformance & market complaints, ensure all investigations/actions are properly evaluated/approved and Corrective and Preventive actions “CAPA” are implemented effectively.
Developing, Monitoring and review/approve quality risk management records, ensure mitigation plan/actions are properly evaluated/approved, Corrective and Preventive actions “CAPA” are implemented effectively and risk is reduced to the acceptable level.
Review and approve Out of Specification “OOS” results, ensure thorough investigations are conducted, provide the needed manufacturing process investigation are properly evaluated/approved and Corrective and Preventive actions “CAPA” are implemented effectively.
Oversee the handling and disposition of rejected materials/products, document all reject handling activities and maintain details record of traceability.
Review and approve batch records including issuance process, test results and other documentation to verify compliance with specification and regulatory requirements before release and distribution to the market.
Conduct and review regular product quality review to evaluate the consistency and compliance of pharmaceutical products, analyze the date to identify tends and area for improvement and prepare comprehensive quality review report with highlight of key finding and recommendations.
Participating the internal audit program to assess compliance with quality standards, procedure and regulatory requirements.
Coordinating the external audits requirements, identifying the required CAPA and ensure effective implementation.
Conduct required training need assessment, develop and implement training programs for QA staff, ensure training completion and participate as trainer in the annual training program.
Coordination and monitoring On-job training program and ensure training completion.
Acting as QA Manager delegate for the respective activities and related area
Bachelor Degree in Pharmacy, Science, Medicine or Chemistry
