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Location:
Seoul, Seoul, South Korea
Job reference: R-043696
Posted date: Jan. 25, 2019
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Purpose of the Job

QC control of all AZK products to be compliant with MFDS regulations and AZ/AZK policies

Typical Accountabilities

  • 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.
    • Secure the package compliance in line with the local regulation and AZ compliance.
    • Ensure that all the quality standards & local regulations are implemented in all the relevant operating guidelines & SOPs in line with Good Regulatory Practice & Good Manufacturing Practice/Good Distribution Practice.
    • 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.

Functional Capabilities

  • Audit & inspection knowledge
  • Quality Management
  • Manage project, risks and opportunities
  • Supplier/partnership management

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.

Apply
QC Specialist
Regulatory

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