Quality Assurance Manager closely organize and manage the Quality Assurance Department by collecting and reporting accurate study data to ensure that quality of products comply with local authority regulations, protocol requirements and Company's objectives and practices.
1. To evaluate the staff performance on their quality and efficiency based on the work assignment given.
2. To review job contribution of the staff and appraise based on the expectation communicated and quality of work done.
3. To develop and recommend the KPI used to appraise staff and get management approval before implementing.
4. To update the departmental scope from time to time by studying trends in and developments in quality management and translate into a KPI.
5. To ensure ongoing compliance with the PIC/S Guideline for GMP.
6. To achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvement; implementing change.
7. To effectively develops, coaches and manages a team a team of quality professionals of Singapore and Malaysia to implement cGMP requirements as per PICs or other recognised reference and continuous improvement in quality operations.
8. Develops and implements a practical system for Quality Management System activities to facilitate smooth, timely workflows in the performance of job function.
9. To provide leadership, guidance, interpretation, information on regulations, laws and industry guidance that affect pharmaceutical industry.
10. Serve as a SME in matters relating to quality assurance and cGMP.
11. Ensure facility follows applicable quality management directives such as SOPs, manuals, policies, procedures, work instruction, etc.
12. Responsible for reviewing, trending and investigating excursions of environmental monitoring and supportive utilities data.
13. The inspection and investigation of product recalls and product complaints to look into factors which has affect product quality.
14. Acts as the Authorised Person to perform batch release and ensure each batch of medicinal products are manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorisation.
15. Reviews, approves or authorises written procedures and other documents, including amendments.
16. Oversees various quality management systems and analyse trending.
17. Reviews and approves deviations and CAPA.
18. Review, approves and implement changes according to established Change Control procedure.
19. Coordinates and participates in quality risk management activities.
20. Initiates investigation for product complaints, reviews and approves corrective/preventive actions associated.
21. Coordinates product recalls, associated reconciliation, documentation and investigations.
22. Reviews, approves and monitors suppliers of materials.
23. Reviews, approves and monitors contract manufacturers and providers of other GMP related outsourced activities.
24. Ensures validation and qualification are carried out according to schedule.
25. Provides training or ensures appropriate training is provided to QA staffs.
26. Monitors compliance of the organisation with the requirements of Good Manufacturing Practice via Internal Audit.
27. Coordinates management reviews of process performance, product quality and Pharmaceutical Quality System and advocates continual improvement
28. Ensures timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
