职位描述：
Principal Accountabilities: Qualifies and implements microbiological methods and procedures to support an aseptic pharmaceutical manufacturing facility. Develops and oversees the daily operation of a QC microbiology group. Ensures the laboratory is maintained in a state of FDA GMP compliance. Reviews and approves analytical QC data, and conduct investigations as an area expert. Participates with senior management in the decision making process for capital equipment expenditures and the acquisition of new technologies. Represents the QC microbiology function during FDA and/or regulatory inspections. Recruit, train and supervise QC analysts. Manage the review of environmental monitory data and trend analysis reports. Recommend actions based on analysis. Track department performance metrics. Basic Function: Supervises the development, implementation, and maintenance of quality control microbiology systems and activities. Oversees development and implementation of standards, methods and procedures for inspecting, testing, and evaluating the quality attributes of products, including the collection and administration of environmental monitoring data, sterility testing, utilities monitoring, and microbial identification. Maintains laboratory in the state of compliance and assists in regulatory audits and investigations. Requirements: BA/BS in Biology, Microbiology, Biochemistry, or other relevant Life Science disciplines 8 years of experience in a pharmaceutical/biotechnology laboratory operations Aseptic process simulation and sterility testing experience for finished dosage parenteral drugs In depth knowledge of current FDA GMP regulations and FDA trends and guidelines Strong leadership, communication, organization and time management skills Ability to read, write, and speak English

企业介绍:

　　迪医猎头（www.rensoo.com）于2003年成立，由几个海外归来的猎头顾问创建，我们服务于药品、医疗器械、医院管理，保健品，还有生物工程，专业专注于医药卫生行业是我们的目标，我们的团队成员由多位经验丰富的具有医药医疗企业背景的猎头顾问组建而成，主要为国际（内）医药企业提供中、高级人才寻访，即猎头服务。

　　我们的猎头顾问均会依靠个人的“能力”、“经验”、“努力”完成任务，我们关注职位成功率和职位完成时间，我们的目标是：“90%职位成功率”和“1-2周之内完成待聘职位初次推荐”。

　　迪医猎头总部位于北京，并通过设在各地的合作伙伴及网络，提供完善的猎头服务，因为专业和专注，有效提高了工作效率，降低了过程成本，从而间接降低客户成本。因为事先关注成本，所以我们向客户进行收费时，通常按行内最低标准进行收取，尽可能保证客户的利益。

　　迪医猎头，专业医药人才资源服务机构。我们吸引了成功的医药猎头顾问，我们拥有高端行业和高端职能岗位相关的专业技术，医药猎头顾问的出众才智改进您的招聘程序，并且使您的公司更好地了解市场和竞争状况。

　　迪医猎头致力于招募全球最优秀的医药高级人才，为优秀的企业提供最合适的医药人才，品质成就品牌，迪医猎头专业医药猎头全力打造医药界高端人才的供需平台！