职责描述： Responsibilities: Manages and coordinates all technical and service aspects of projects, to ensure GMP packaging jobs well implemented, including both physical and documentary, especial focus on production order generation.
1. Assessment of clinical protocol and other client supplied study specifications in conjunction with client service and procurement to help design packaging solution to meet the needs of the trial.
2. Coordination and communication of all relevant activities, both internal and external to ensure that all services and products are ready for the start of the study or as required by the client.
3. Overall responsibility for ensuring that activities come together in a timely manner to meet the client and study requirements.
4. To generate packaging documents, including but not limited to electronical production order (EPO), assemble diagram, labeling checklist, etc.
5. Organization and delivery of EPO training to all relevant technicians before packaging jobs physical starting.
6. To ensure the packaging jobs are implemented in accordance with EPO and established procedures.
7. Review of departmental SOP’s and writing of documentation for the control of packaging operations.
8. To support supervisor to schedule and optimize the production of clinical supplies – balancing the client requirements with best use of available production capacity.
9. To support supervisor to oversee day to day operation and labeling and secondary repackaging team to ensure all processes are compliant to quality and SOP standard.
10. Assistance to ensure the facility are maintained to cGMP standards.
11. Has no authority in making any financial decision.
Education: Preferred College diploma above. Pharmaceutical or biological preferred. Vocational diploma may be considered if with very strong working experience.
Years of Experience:
3-5 yrs of working experience in logistics, warehouse or manufacturing environment. Experience in pharmaceutical or biological or food industries will be a plus.
Good command of English (CET4 or CET6 preferred) and mandarin. Good command of computer skills (MS Office. Good understanding of pharmaceutical industry will be a plus.
1. Interpersonal skills/Communication
2. Driving for success
3. Analytical Decision Making
4. Customer Focus
5. Managing and Initiating Change
7. Ability to deliver accurate and precise information to clients and internal team.
1. Relevant experience of clinical trial and clinical trial packaging, preferably to include handling complex protocols, key clients and business objectives are preferred.
2. Understanding of logistical countries requirements.
3. Flexible and adaptable with strong customer management skills.
4. Able to analyze problems and define solutions.
5. Able to work under pressure and to support others within team.
6. The post holder needs to have good organizational, verbal, written and numerical skills
Fisher Clinical Services is a part of the CTD of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $10 billion, we have more than 30,000 employees and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.