[ROLES]

1. Review batch record of the CMO products

2. Review key Deviations/OOSs proposed actions including assessing risks prior to allowing CMOs to continue

operations and/or releasing products to markets

3. Preparation of Product Quality Review report for the CMO products

4. Preparation of Master Product File for the CMO products

5. Customer Complaint Management for local CMO products

6. Preparation CTD for local CMO products

7. Artwork - Technical Review for CMO products

8. Quality Technical Agreement Annual Review

9. Updating and creating of SOPs and Templates

10. Preparing the GxP documents

[QUALIFICATIONS]

1. More than 2 years’ experience in the QA department of the pharmaceutical company.

2. Bachelor’s degree or above, majoring in chemical engineering, biotechnology, Pharmaceutical Engineering

or related

3. To be well acquainted with the MFDS standards, and preferably also European standards on Good

Manufacturing Practices (EU-GMP), as well as other international GMP/GIP standards.

4. Recommendation: Good English communication skill, OA skill