工作職責:
1.負責GMP相關文件和記錄的管理工作;
Be responsible for the management of GMP related documents and records
2.負責壓縮空氣、氮氣質量檢測;
Responsible for the quality inspection of compressed air and nitrogen;
3.負責對有關影響產品質量的因素進行監督,并負責問題的糾正、偏差分析處理以及相關過程的管理及風險管理;
Supervise the factors affecting product quality, and take charge of problem correction, deviation analysis and handling, as well as management and risk management of relevant processes;
4.負責現場質量監督工作及潔凈室環境監測工作;
Responsible for on-site quality supervision and clean room environment monitoring;
5.負責原輔料、半成品、成品、包裝材料及工藝用水的取樣;
Take samples of raw and auxiliary materials, semi-finished products, finished products, packaging materials and process water;
6.負責公司的物料、產品放行,在產品放行前完成對批記錄的審核,確保每批放行的產品符合相關法規、藥品注冊和質量標準;
Be responsible for the release of the company's materials and products, complete the review of batch records before the release of products, and ensure that each batch of products released complies with relevant regulations, drug registration and quality standards;
7.負責公司與質量有關計算機系統操作權限的審核。
Be responsible for the audit of the company's computer system operation authority related to quality.
任職要求:
1.有QA工作經驗者優先考慮;
2.大專及以上學歷;
3.熟練使用計算機辦公軟件,熟悉GMP管理要求;
4.善于溝通,工作認真仔細,態度積極努力
注:該崗位為現場QA,因工作需要跟生產部門出勤時間保持一致,能接受倒班再行投遞,謝謝!
職位福利:周末雙休、五險一金、定期體檢、帶薪年假、節日福利、餐補、加班補助、交通補助
職位亮點:外企,雙休五險一金,免費工作餐及市內班車