Quality Management
- Extend GSP of Company in timely manner
- Updates job knowledge by studying trends in and developments in quality management, participating in edicational opportunities, reading professional publications, maintaining personal networks, participating in professional organization
- Review and release for sale or reject imported products/ printed packaging material/ returned goods including biological products
- Set up internal audit to Quality Management System (QMS), risk management in general
- Setup quality assurance operational objectives, and risk analysis to strategic plans and reviews, prepare and complete action plan, identify and resolve problem, CAPA, complete audits, determining system improvements , change management
- Ensure to implement the recall activities properly once receiving the request from Authority. Handling complaint including counterfeit product in compliance with regulation and procedure of Company.
- Maintain, improve the Quality Management System (QMS) of GSP warehouse.
Warehouse management
- Review continuous training program for all personnel involved in storage activities
- Supervise Quality staff/ EHS staff engaged in inspection and testing activities to ensure high productivity and high technical integrity.
- Ensure the validation/ calibration activities to be implemented under the current process, the plans were approved and validation protocol correspond to each type of validation
- Review & improve the redressing procedures to guide the redressing team, instructions of warehouse, quality management on product label
3
Third party management
- Sub- contractor, vendor management: Assess and approve vendor, sub- contractor in scope of GSP.
HSE
- Establish, maintain EHS system of GSP warehouse and Eisai offices.
- Cooperate and support warehouse supervisor in inbound- outbound activies where applicable and handle deviation, technical issue happened at GSP warehouse and/ or Eisai offices
- Set up internal visit to EHS at warehouse, risk management in general frequency (at least once per month via walkthrough)
