长沙招聘

Core business/Functional skills and education:
1. Must have experience in GMP quality assurance.
2. Must be trained in or have experience with the requirement of SFDA, FDA, EMEA GMP regulation.
3. BS, MS or PH.D degree in a science discipline with experience or training in Chemistry, Pharmaceutical, or equivalent experience.
4. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
5. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.


Key accountability:

1. Be responsible for conducting production on-site inspection / in-process control.
2. Be responsible for ensuring that the raw materials, packaging materials and intermediate, bulk and finished product are approved or rejected according to defined procedure or specification.
3. Be responsible for ensuring medicinal products are stored, distributed and subsequently handled as the requirements of defined procedure throughout their shelf life.
4. Be responsible for ensuring specifications, sampling instructions, test methods and other procedures related with GMP operation are effective before using.
5. Be responsible for supporting the validation activities and ensuring that the appropriate validations are done according to VMP and defined procedures.
6. Be responsible for reviewing batch record and ensuring the operation complies with defined procedures.
7. Be responsible for coordinating deviations, making sure the corrective or preventative actions are carried out and documented and maintaining the trace system to prevent deviations from re-occurring.
8. Be responsible for coordinating change control, making sure any change are documented according to defined procedure and all impacted items are investigated and evaluated, making sure the proposal changed implement as the requirements of pre-defined protocol.
9. Be responsible for taking part in the investigation, documentation and communication of GMP nonconformity.
10. Participating internal audit and routine inspection.
11. Be responsible for Periodical quality review with other departments
12. Any other job and responsibilities assigned by supervisor

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