職位描述
職位描述：
四川海銳特藥業有限責任公司的新廠位于成都市高新西區，注冊資金一億元，新廠占地72畝。新廠計劃于2019年將建成符合中國CFDA，歐盟EMA及美國FDA的cGMP標準的現代化基地。
歡迎您應征微生物質檢主任 (Microbial QC Lab Supervisor )！
1 Position Summary/ 工作綜述: Microbial Laboratory operation in supporting plant operations and in compliance with regulatory requirements. /微生物實驗室操作滿足工廠運行和法規要求。
2 Essential Functions/ 關鍵工作:
2.1 The person will be responsible for the management procedures and standard operating procedures for Microbial Laboratory. /負責微生物實驗室的管理規程和操作規程。
2.2 For methods validation of the microbiological testing. /負責微生物試驗的方法驗證。
2.3 For the operation of instruments, implements, consumables ect., also ensuring which comply with GMP./確保微生物實驗室的檢驗用儀器、器具、耗材等順暢操作并符合GMP要求。
2.4 For the Microbial Lab personnel management and training /負責微生物實驗室人員管理和培訓。
2.5 Participate in various C&Q work, including process verification, equipment cleaning method verification, water and air system verification, etc../參與工藝、設備清潔方法、空調系統、水系統等調試和確認工作。
3 Education/ 教育背景：
3.1 Bachelor or above degree in Biology or Pharmaceutical related fields./生物或醫藥相關專業本科及以上學歷。
4 Experience/ 經驗:
4.1 At least 5 years working experience in microbiological testing in pharmaceutical factory./至少5年藥廠微生物檢驗的工作經驗。
4.2 Must be familiar with the environmental monitoring, microbial limit test, sterility test./熟悉環境監測、微生物限度檢測和無菌檢測。
4.3 Preferred to the person with the experience of FDA, EMA GMP regulations./有FDA、EMA GMP法規要求的經驗者更佳。
4.4 In-depth exposure to the pharmaceutical quality system requirements and with ability to implement PQS./對制藥企業的質量體系要求有良好的執行經驗，并有能力實施。
4.5 Communication and teamwork skills./較強的溝通和團隊合作能力。
5 Skills and Knowledge/ 技能及知識:
5.1 With English reading and writing ability./具有英語讀寫能力。
5.2 Word, Excel, PowerPoint or equivalent required./Word, Excel, PowerPoint或其他作業軟件。
