Purpose of the Job

QC/QA control of all AZK products to be compliant with MFDS regulations and AZ/AZK policies including Good Manufacturing Practice / Good Distribution Practice (GMP/GDP)

Typical Accountabilities

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.

Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance

Functional Capabilities  (that are most critical to this position)

• 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 AstraZeneca Korea 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 imp​orted 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.

Essential Qualification

- More than 3 years of experience in the quality department

- Knowledge of the QA/QC area

- Good command of spoken and written English

Desired skills or requirements

- Pharmacist

- Experience of working on R&D laboratory.

Date Posted

11-3월-2021

Closing Date

11-3월-2021

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.