Location Suzhou ShiFULL_TIME
Consultant Kathleen Zhao
Date posted 10 April 20192019-04-10 2019-06-09 pharmaceuticals Suzhou Shi Jiangsu CN CNY 800000 1200000 1200000 YEAR Robert Walters https://www.robertwalters.cn
As a Sr. QC Director, you will Provide leadership and direct the daily activities of the Quality Control department and functions at Suzhou manufacturing facility. Establish and maintain Analytic and Laboratory controls to ensure compliance with applicable regulatory and internal requirements.
- Responsible for oversight and direction Quality Control operations at CMAB’s Suzhou manufacturing
- Analytical Transfers
- Analytical Method qualification & Validation
- Laboratory Controls
- Establishment and maintenance of QC specifications as required
- Process and cleaning validation.
- Generation and maintenance of Master Method Validation Plan
- Management of Third Party QC Labs and Support Service providers
- B.S. (preferably Biology or Chemistry) plus a minimum of 7 years responsibility in the management of quality and compliance systems for the manufacture of therapeutic biologic.
- At least five years of operational experience in a regulated bio pharmaceutical manufacturer with exposure to facility start-up.
- Thorough knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) encompassing documentation and operation of pharmaceutical facilities including Eudralex, PIC/S and US-FDA with focus on biological API and sterile product manufacture.
About the Organisation:
A full-service contract development and manufacturing organisation (CDMO), which is dedicated to providing process development and manufacturing services for biologic products.