As the Director of Quality Control you will report to the VP of Biologics CMC Operations and provide direction and tactical leadership to the Quality Control of Biologics Development and Manufacturing. In this position you will lead managers (or supervisors), each is responsible for specific quality control functional areas (QC-Raw Material, QC-Chemistry, QC-Biochemistry, QC-Microbiology, etc.), and many indirect reports from Quality Control.
You will define, implement, and manage the various quality control programs needed to ensure compliance of the company with Good Laboratory Practices.
Quality Control ensures that the products manufactured by and for ChemPartner Biologics are tested in conformance with appropriate standards of identity, purity, and safety.
Manage and coordinate the activities of the Quality Control group in support of biopharmaceuticals produced in the cGMP facility including: oversight of analytical (protein) and microbiological in-process, release and stability testing, the environmental monitoring and raw material programs deviations; draft and revise SOPs; staff training and development. Report directly to the VP of Biologics CMC Operations. The individual must be; a self starter, problem solver, flexible in work assignments, and a Team player working with all echelons of Management and Staff.
Requirements:
- Oversee all Quality Control laboratory procedures and related testing, data review, trending, interpretation and reporting of results.
- Oversee analytical (protein) and microbiological in-process, release and stability testing and the environmental monitoring and raw material programs.
- Coordinate cross-functional, intra-group and inter-group work assignments and address scheduling conflicts.
- Provide guidance on the resolution of EMIs, deviations, OOS and CAPAs.
- Oversee and lead problem solving and troubleshooting; identify and resolve technical testing issues; review and approve investigation reports.
- Devise, implement and maintain quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment, compliance with federal regulations, prepare and maintain applicable records.
- Oversee the EM trending and publish quarterly and annual reports.
- Ensure proper transfer and validate QC methods.
ShangPharma, the holding company of Shanghai ChemPartner Co. Ltd. and Shanghai ChemExplorer Co. Ltd., is one of the largest CROs (Contract Research Organizations) in China and provides a comprehensive portfolio of services to global pharmaceutical and biotech companies. We have a team of skilled scientists and a problem-solving culture that enable us to respond to our clients' toughest challenges. Headquartered in Zhangjiang Hi-Tech Park, Pudong New Area of Shanghai, ShangPharma currently has a staff of more than 1,600 scientists in virtually every discipline. Over 40% of our scientific staff have post-graduate degrees and all of our top scientific leaders have U.S. and/or European industrial experience in major international pharmaceutical and biotechnology companies. To keep up with the growing demands for R&D outsourcing, we are looking for experienced candidates who thrive in a paced research organization.
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