職位描述
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職位職能:
??質量管理/測試工程師(QA/QC工程師)??體系工程師/審核員
職位描述:
崗位職責：
1. Quality Document System 質量保證體系文件：
Write position related SOPs by both English and Chinese when needed.
確保文件體系結構與文件格式符合GMP要求。編寫個人崗位工作有關的SOP，必要時，英漢雙語。
2. Batch Review物料和產品批審核
Collect batch records relevant departments and review batch records in time, ensure that batch material and the product to release in time.
負責接收來自生產部、物管部、質控部的批記錄；整理、審核每批物料和產品的批記錄，確保物料和產品及時放行。
Communicate with the manufacturing site about the quality defects of bulk product.
負責與生產廠聯系待包裝品供貨缺陷。
3. Printed packaging materials artwork control標簽類印刷包裝材料的印前管理：
Ensure that the printing packaging material meet the requirements of SFDA regulation.
管理標簽類印刷包裝材料的制訂和修訂改版符合藥監法規的要求。
4. Responsible to organize annual product quality review負責組織定期的年度質量回顧
Ensure annual product quality review accomplished in time. pre
確保質量回顧及時完成。
Write summary report of annual product quality review for management approval.
編寫年度回顧的總結報告提交管理層批準.
5. Quality specification and stability studies質量標準和穩定性研究：
Review quality specification. Ensure the specification compliance with GMP and pharmacopeia requirements
審核質量標準，確保標準符合GMP和藥典標準要求。
Be responsible for review analytical method validation.
負責審核分析方法學的驗證文件。
Write stability study protocol. Check the implementation of the stability tests on-line.
制訂穩定性研究方案。定期跟進穩定試驗進度。
6. 驗證支持support qualification and validation
Review IQ/OQ/PQ periodical report.
審核IQ/OQ/PQ階段性驗證/確認報告。
7. Deviation/OOS/Change control/CAPA 偏差、OOS、變更、CAPA
Review deviation, change control and OOS investigation document related with batch review and ensure there is no adverse impact on the batch quality before release batches.
審核與批產品和物料有關的偏差、變更和OOS調查文件，確保偏差、變更、OOS對批質量無負面影響。
Implement CAPA action related.
執行批放行職責范圍內的CAPA行動。
8. Communicate with Zhuhai SFDA負責與珠海SFDA的聯系
Keep communication with city SFDA to response SFDA requirement timely
與市藥監部門保持聯系，及時回復藥監局的要求。
JOB PROFILE (Education & Experience)
崗位要求 (
學歷及經驗)
Education 學歷
Bachelor or above degree of Pharmacy or relative profession.
藥學/制藥專業或相關專業，本科及本科以上學歷。
Experience
經驗
At least five years working experience for drug manufacturing or quality in pharmaceutical enterprises.
五年以上從事藥品生產技術或質量管理工作經驗。
