我们的客户是一家以创新研发驱动并致力于协同创新的制药公司，目前正在招聘QC head of Biologics。
地点：南京
薪资：70-100万
工作职责：
1.Lead and manage the QC team for overall QC activities in compliance with cGMP; 2.Lead the technology transfer of analytical methods, testing protocols, etc; 3.Provide guidance and oversee method qualification/validation, troubleshooting, laboratory and OOS investigation; 4.Manage the overall QC operations to support GMP operations; 5.Manage the program of testing encompassing raw materials, environmental monitoring, testing critical utilities (e.g. WFI, PW, special gases, HVAC), intermediates, bulk drug substances, and drug products are required; 6.Review and approve technical documents such as methods,qualification/validation protocols and reports; 7.Participate in investigation teams, and provide input to quality systems (change control, CAPA, and deviations); 8.Promote collaboration and communicate with other functional areas to ensure timely completion of QC activities to meet project timeline; 9.Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs.
工作要求：
1.M.S. or Ph.D. (preferably Biology or Chemistry) or related life sciences degree;
2.Minimum 5 years of relevant experience that demonstrates an expertise in assay qualification/validation, release and stability testing and QC operations.
顾问邮箱：joy.chen@recotalent.cn
