職位描述：
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

企業介紹:

　　迪醫獵頭（www.otkrivenozdravlje.com）于2003年成立，由幾個海外歸來的獵頭顧問創建，我們服務于藥品、醫療器械、醫院管理，保健品，還有生物工程，專業專注于醫藥衛生行業是我們的目標，我們的團隊成員由多位經驗豐富的具有醫藥醫療企業背景的獵頭顧問組建而成，主要為國際（內）醫藥企業提供中、高級人才尋訪，即獵頭服務。

　　我們的獵頭顧問均會依靠個人的“能力”、“經驗”、“努力”完成任務，我們關注職位成功率和職位完成時間，我們的目標是：“90%職位成功率”和“1-2周之內完成待聘職位初次推薦”。

　　迪醫獵頭總部位于北京，并通過設在各地的合作伙伴及網絡，提供完善的獵頭服務，因為專業和專注，有效提高了工作效率，降低了過程成本，從而間接降低客戶成本。因為事先關注成本，所以我們向客戶進行收費時，通常按行內最低標準進行收取，盡可能保證客戶的利益。

　　迪醫獵頭，專業醫藥人才資源服務機構。我們吸引了成功的醫藥獵頭顧問，我們擁有高端行業和高端職能崗位相關的專業技術，醫藥獵頭顧問的出眾才智改進您的招聘程序，并且使您的公司更好地了解市場和競爭狀況。

　　迪醫獵頭致力于招募全球最優秀的醫藥高級人才，為優秀的企業提供最合適的醫藥人才，品質成就品牌，迪醫獵頭專業醫藥獵頭全力打造醫藥界高端人才的供需平臺！