- Maintain and contribute into quality system continuous improvement;
- Finish other tasks assigned by supervisor.
- Responsible for daily management of QA for QC group.
- Review and approve QC related SOP and analytical method.
- Online monitoring of QC site operation.
- Review and approval of QC protocol.
- Support for review of QC test results and test record.
- Support for release of QC test data & CoA review.
- Review EM trend analysis report, review and approval for OOL investigation.
- Routine monitoring of QC instruments calibration and maintenance.
- Review and approval for QC deviation, change control, OOS/OOL investigation.
- Support for internal audit and external audit.
- Enhance current service offering and communicates with clients.
- Senior lead team members of Quality Control group to support biomanufaturing at Wuxi and interact with Protein Analytical Science groups at Shanghai and Wuxi sites of WuXi Biologics.
- Provide technical leadership and trouble shooting for all aspects of QC assays for broad portfolio of biologics.
- Recruit, train and retain a high performance team to ensure beat quality control testing services.
- Oversee the Raw material Testing Group/ RM testing Centers of Excellence; provide technical leadership in raw material testing strategy development & establishment and routine operations.
- Develop and build up raw material resting teams and testing capabilities.
- Improve raw material testing system and procedures to enhance raw material testing quality, efficiency, and TAT.
- Interact with clients as a QA Sponsor or CMC RM Lead and interact with CMC project teams to support IND and BLA filing.
- Lead QA group supporting biologics manufacturing for areas that include product testing, process validation, CIP and SIP validation, facility validations and EM for air, surfaces, water system, and air/ gas distribution system.
- Lead facility microbial control strategies to ensure that the facility EM is under control.
- Provide oversight for laboratory investigations and reports in responses to OOS, adverse trends, manufacturing investigation for contamination investigations and utility and environment excursions, including root cause analyses and preventative action proposals and initiatives.
- Develop and ensure implementation of plans to continuously compliance and efficiency with the QC laboratories in support of business objectives for laboratory and site operations supporting biopharmaceutical products manufacturing and release.
- Provide technical guidance/direction to subordinates, as well as evaluate new analytical technologies to enhance new capabilities.
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
Head of QA for QC
Head of QA for QC
中国 无锡
工作职责：
任职能力：
- Ph.D or M.S. in Analytical chemistry, organic chemistry, biochemistry, or related fields.
- Profound English knowledge both written and oral;
- Excellent communication and negotiation skills;
- Good team work ability;
- Strong sense of service, decisiveness and responsibility;
- Familiar with China, USA, and EU GMP regulations requirements for quality control and laboratory management;
- Knowledge in FDA/EMA/CFDA cGMP regulation, Pharmacopoeias, and ICH guidelines.
- Knowledge and experiences in analytical method development, qualification, and validation.
- Experience in Pharmaceutical/ Biopharmaceutical industry and team management experience are highly desirable.
- Familiar with raw material requirements of FDA, EMA, and CFDA/NMPA regulations; ICH and GMP guidelines;
- Knowledge and expertise in some of following fields; Analytical method development/ validation. Extractable/leachable studies. Analytical instrumentations and raw material resting, such as HPLC/UPLC,GC,IR, Raman, MS, and related chemistry/physical analyses, etc.