1. Support activities to maintain the quality system and execute tasks in compliance with Amgen’s Quality Management System, GDP/GMP requirements and any local applicable regulations.
2. Completes required assigned training to permit the execution of required tasks.
3. Conduct GSP remote and on-site Due diligence visit and/or Inspection, may extended to GMP related.
4. Alerts any quality, compliance, supply and safety risks.
5. Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
6. Conduct Product complaint outbound work per the guidelines, such as reconciliation of Product complaint samples.
7. Communicate with Logistics service partners and cross-functional departments for routine tasks, and physical visit to LSP/distributors.
8. Manage documentation and the archive of all the relevant documents.
9. Support Company Secretarial affairs when needed.
10. Implement continuous improvement practices and work hard to meet organizational objectives.
11. Performs review and tracking of cGMP/GDP and QMS processes documents and records.
12. Experienced in planning, organizing and problem-solving to complete multiple deadline-driven projects efficiently and on time.
Qualifications:
1. Bachelor’s degree in pharmacy or related majors, Overseas education is preferred.
2. Above 3-5 years experience in a pharmaceutical company, preferred to have quality function experience in a distribution company, manufacturing site and/or auditing function.
3. Has knowledge of local regulations related to Good Distribution/Supply Practice (GDP/GSP) and Goo