700 - 900 $
* ROLE AND RESPONSIBILITY
- This position reports to the QA manager and plays a role for Changecontrol, Deviation, CAPA, Out of specification, Vendor qualification, market complaint, product recall, rejected of raw material, packaging material, internal and external audit and all relevant documents.
- This position shall be responsible for coordinating with QA staffs and other departments to solve the assigned works and accomplish the jobs required by QA manager
* TASKS AND RESPONSIBILITIES
1. Change control: form issue, change control assessment, submit for approval, monitoring and close change control
2. Deviation control: form issue, deviation assessment, submit for approval, CAPA monitoring and closing deviation
3. Market complaint: Inform issue, assessment and monitoring of implementation submit to QA Manager to review/ approval.
4. Product return: Inform issue, assessment and monitoring of implementation submit to QA Manager to review/ approval.
5. Reject of RM, PM: Inform issue, assessment and monitoring of implementation submit to QA Manager to review/ approval.
6. CAPA: form issue, assessment and monitoring of implementation, evaluate after completed implementation and close CAPA
7. Vendor qualification: planning, submit for approval, assessment deployment and reporting qualification.
8. Preparation, review, storage of the relevant documents.
9. PQR: colletting the data from related department, reviewing and completion of PQR report submit to QA Manager to review/ approval.
10. Compliance the observations of incoming audits within the time frame.
11. Complying with the provisions of the current pharmaceutical regulations and fully implementing the GMP requirements at the factory.
12. Co-ordination for the on the job training of personnel
13. Should follow the safety precaution wherever applicable
- Age: Under 35
- Qualification of Pharmacist
- More than 3 - 5 years' experience of QA in pharmaceutical manufacturing factory
+ Must requirements
- Knowledge about statistic quality control (quality control chart, process capability、statistical test, sampling inspection criteria, etc.)
- Careful, honest, possitive and co-operation attitude
- Ability to work in groups
- Analytical skills and scientific work
- Sufficient technical capabilities and people management experience as a mid-career
- English or Japanese: Intermediate level or above
- Professional working environment