대전 바이오 공장 신설 - Daejeon

Job summary

Build and develop site Quality Control organization of new site to ensure sufficient resource and capabilities in place for the lab operations and continues improvements.

Responsibilities

• Build and develop site Quality Control organization of new site to ensure sufficient resource and capabilities in place for the lab operations and continues improvements.
• Ensure QC employees are hired, trained, and qualified to support project execution and conduct daily operational activities.
• Establish QC management systems, procedures, and other required analytical documents e.g. specifications, methods, logbooks in the new facility to ensure that QC operations comply with company standards and customer expectations.
• Closely work with project team to design and establish QC labs in the new facility. Ensure operational readiness of QC labs to support project qualification, validation activities.
• Define user requirement specification of QC equipment and support equipment procurement.
• Responsible for qualification of QC equipment, clean room, and clean utilities; analytical method validation, computerized system validation of QC systems. Support cleaning validation and process validation.
• Support tech transfer of products from giving sites and ensure equivalent quality.
• Overall management of daily QC operations (biological lab and chemical lab) in the new facility. Scope of responsibilities include but not limited to:
• Sampling and testing of raw material, packaging material, finished product.
• Daily operation of chemical lab and microbiological lab.
• Environmental monitoring and clean utility monitoring.
• Sample retention and stability study.
• Calibration and maintenance of QC equipment and instruments.
• QC resource management and people development.
• Manage lab consumables e.g. chemical reagent, culture media.

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