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, , South Korea
Job reference: R-044034
Posted date: Jan. 30, 2019

Purpose of the Job

QA control of all AZK products to be compliant with MFDS regulations (KGSP and Regulation on Management of Imported Drugs) and AZ/AZK policies as Registered Pharmacist for KGSP and Imported Drug Management (dual hats).

Typical Accountabilities

1. Dedicated QA Pharmacist

  • Play a role as a dedicated QA pharmacist for wholesale products and imported products control

2. Product management from incoming to release

  • Perform incoming inspection upon product arrival with inspection checklist
  • Responsible for reporting any defect / problem upon product arrival that potentially affect the product quality
  • Perform sampling for QC test, and reserve samples
  • Maintain imported product logs
  • Verify and maintain incoming product documents including packing list and CoAs.
  • Approve product release by verifying all the relevant documents
  • Prepare and maintain product batch release logs including quality control data every batch basis
  • Manage the deviation of product appearance and quality control result

3. Re-dressing process management

  • Decision making for redressing and get the pack conversion approval
  • Supplier management for re-dressing materials
  • Prepare redressing instruction document and train for operators
  • Supervise on-site operation by verifying clean-up, re-conciliation process
  • Responsible for the approval of the execution of the re-dressing operation prior to release of the product to the market

4. Prepare and maintain KGSP documents

  • Develop KGSP SOP and responsible for implementation
  • Prepare and maintain KGSP documents according to the KGSP requirements : quality inspection report, Environment monitoring , Equipment check ,Temperature/humidity monitor
  • Return/destruction management record
  • Manage self-audit for KGSP warehouse
  • Train quality and supply personnel and maintain related record

5. Overall control of QA requirements at warehouse

  • Ensure that controlled drugs are stored in safe, dedicated and secure areas according to the relevant regulation requirements and AZ/AZK policies
  • Ensure that products are physically segregated for the storage of quarantined, expired, returned, and recalled product
  • Follow up government inspection for importing and KGSP

6. Relationship with customers(internal & external)

Maintain high level of authorities’ satisfaction through application of high professional standard in all contacts, quick resolution of authorities’ enquiries and provision of support.

  • Maintain positive relationship with local contractors, customers and internal staff.
  • Comply with the relevant regulations and AZK’s ethical business practices with full understanding of the code of conducts.

7. 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.
QA Manager(Location Ochang)

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