About the Job
To manage the Operations of Fisher Clinical Services Japan facility in accordance with cGMP standards, and to lead teams of staff to achieve the company goals and objectives.
Operation team is composed of 4 groups - Warehouse operation, Packaging and Labeling, Bio-Bank (Cell & Gene Therapy) operation, and Logistics Admin. This position is responsible for all four related activities and the staff.
- Supervise and ensure that the staff are working in accordance with cGMP standard and Standard Operating Procedures (SOPs)
- Ensure that the operation is well maintained in accordance with cGMP including the activities of Warehouse operation and Packaging/Labeling production, Bio-Bank operation, and Logistics Administration.
- Ensure that all processes are performed in accordance with c GMP
- Ensure that the inventory of supplies is accurately maintained with the supporting documentation
- Ensure that all personnel are adequately trained and the training record is maintained
- Ensure the Japan facility has efficient capacity and resources to support daily activities
- Ensure customer satisfaction by providing excellent operation and service particularly at the stage of project introduction and implementation
- Support QA Group on the preparation and smooth conduct of internal and external audits
- Achieve operation excellence by continuously improving on operation quality, efficiency, and cost reduction
- Work with the Finance in responsibility for operation costs and reporting
- Minimum 3 years of management of pharmaceutical logistics/Warehouse in accordance with GMP
- Degree holder/ Degree in engineering is preferred
- Strong written and oral communication skills in Japanese and English
- Dynamic and highly self-motivated individual