Quality Assurance Manager (반월공장)

[Job Description]

​1. Set up and maintain the GMP compliance system: bring, identify, stimulates the awareness of the GMP regulations of headquarter and authority regulations to plant to assure the compliance with GMP requirements
2. Set up and maintain the GMP documentation and the GMP training system
3. Approval of GMP or GSP/Medical device quality relevant documents
4. Maintaining a permanent preparedness for inspections by Korean and international agencies
5. Handling of claims and reports of complaint / counterfeit issues regarding products
6. Leading the preparation of Product Quality Reviews (PQR)
7. Facilitation and documentation of the “Continuous Process Verification” and process qualifications
8. Consulting and supervision of the departments of the Supply Center with regard to pharmaceutical risk to ensure the market supply
9. Ensuring that the specifications/regulations in the GMP-systems are implemented in the local list of indications and systems
10. Ensuring that CMS regulations (Global SOP, Global Operational Instruction, etc.) are implemented and translated in local indications as far as relevant
11. Supervision of the product change management
12. Supervision of Supplier management (Audit, QAA, Risk assessment)

[Job Requirement]

- Pharmacist
- Profound Knowledge of GMP-regulatory requirements from authorities (FDA, EMA, WHO and more), GMP group regulations and local regulations
- Ability to deal with customer and authority inspectors
- Understand and incorporate the impact of quality and safety related issue management on the authority awareness and the public image of the company
- Proven personnel leadership responsibility
- Coordinative activities (operational excellence, process guidance…)
- Proven ability to act in a flexibly
- Knowledge about pharmaceutical products, production and Quality processes especially on sterile manufacturing
- Profound knowledge about legal framework and QC requirements
- Profound knowledge about process qualification and validation
- Knowledge about quality requirement and content of CMC documentation
- Good English skill
- Logical thinking & Problem solving skill
- Familiar with MS office (WORD, EXCEL, POWERPOINT)