- Management of local testing to support the market activities
- Manage a process of Analytical Technology Transfer from the donor lab to the receiving lab in order to secure the implementation timeline and compliance to local regulation.
- Manage the supply of reference standards & testing samples to support local testing
- Manage the deviation of the local test such as OOT (out of trend) and OOS (out of specification).
- Management, documents and inspection of the third parties from various stakeholders.
- Support New Drug/ Biologics Application or Life Cycle Management in terms of quality (Chemical, Manufacturing and Controls).
- Management of the quality system in Conpany in line with registered product information.
- Ensure that all the quality standards & local regulations are implemented in all the relevant operating guidelines & SOPs
- Prepare for regular inspection of MFDS
- Review local SOPs concerned and update
- Management of Product Quality Complaint
- Handling of the complaints for imported products and toll manufacturing products
- Upload and report information on any complaint of the imported product regarding technical/pharmaceutical quality GCM or local manufacturer
- Sending samples to the concerned Production site
- Investigate and discuss with sales & MKT to coordinate correctly
- Confirming feedback of the complaint from Production site
- Providing the customer with an adequate reply based on the investigation made by the Production Unit
- Intelligence Gathering
- Get any information relating to changes in the relevant regulatory regulations and health authorities and report to RA manager on any expected impact on our business.
- Develop/maintain good relationship with government agencies and regulatory bodies to achieve above.
Education, Qualifications, Skills and Experience
- More than 3 years of experience in the quality department
- Knowledge of the QA/QC area
- Good command of spoken and written English