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QC Lab Manager[¿Ü±¹°è Á¦¾à/¹ÙÀÌ¿À ±Û·Î¹ú ´ë±â¾÷]
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¿Ü±¹°è Á¦¾à/¹ÙÀÌ¿À ±Û·Î¹ú ´ë±â¾÷
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[Responsibilities]
1) Lab Manage
- Overall management laboratories (Analytical, RM, PKG & Micro)
- Ensure GMP, GLP and safety in Laboratories
- Trouble shooting
- Review all testing for FG analytical test, FG micro testing, RM testing, PKG testing, stability
- Review document (raw data, log books, calibrations, SOP, protocol & report, qualification, OOS(LIR),
OBS, Non-conformance, test result)
- Calibration management
- New employee qualification.
- Introducing new/revised WWSP & QSP
- Manage equipment qualification & validation
- Bulk release, Empower approval, GSS form approval, PC spec approval
2) New product support
- Coordinate for test method transfer & MS from R&D or transferring site
- Scheduling & handling stability testing
- Getting document for product spec, TMV, MS, NPMR from R&D
- Review test request
3) GMP & Safety
- Joined Gemba walk with cross functional team
- Manage safety in laboratories with ESH team
- To issue & follow up the EtQ/ GSS
4)OOS/NC follow up
- Communicate with related suppliers to follow up issues
- Review all investigation report
5) People development to Subordinates
[Á¸½¼¾ØµåÁ¸½¼] QC Lab Manager
- Set the yearly training plan for laboratory
- Strengthen Leadership set and improve the quality and inspection skill
6) Site lead for Analytical & Micro Community of practice in AP
7) Back up & Support
- For Site Q&C head to make a right decision
- For analytical lab activity
- For RM lab activity
- For PKG lab activity
- For Micro lab activity
ÀÚ°Ý¿ä°Ç
*
[Requirements]
1) Minimum Bachelor¡¯s degree with Pharmacy, Science or Chemical Engineering, Microbiologist
2) Over 8 years¡¯ experience in Pharmaceutical, Cosmetics industry
3) Solid knowledge of local regulations, cGMPs, Quality Assurance, Audits & Regulatory Compliance,
etc.
4) Fluent in English both oral or written
5) Sufficient knowledge on manufacturing processes
6) Leadership, collaboration and interpersonal skills
7) Good communication and presentation skills
8) Decision making and problem solving
*
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´ã´çÄÁ¼³ÅÏÆ®: ±è½ÂÈ Àü¹« / 070-4477-3093 / 010-5115-7540 /
jason_kim@careerconnect.co.kr
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