職位描述
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職位職能:
??質(zhì)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(zé)：
1. Quality Document System 質(zhì)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(jié)構(gòu)與文件格式符合GMP要求。編寫個(gè)人崗位工作有關(guān)的SOP，必要時(shí)，英漢雙語。
2. Batch Review物料和產(chǎn)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(fù)責(zé)接收來自生產(chǎn)部、物管部、質(zhì)控部的批記錄；整理、審核每批物料和產(chǎn)品的批記錄，確保物料和產(chǎn)品及時(shí)放行。
Communicate with the manufacturing site about the quality defects of bulk product.
負(fù)責(zé)與生產(chǎn)廠聯(lián)系待包裝品供貨缺陷。
3. Printed packaging materials artwork control標(biāo)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(biāo)簽類印刷包裝材料的制訂和修訂改版符合藥監(jiān)法規(guī)的要求。
4. Responsible to organize annual product quality review負(fù)責(zé)組織定期的年度質(zhì)量回顧
Ensure annual product quality review accomplished in time. pre
確保質(zhì)量回顧及時(shí)完成。
Write summary report of annual product quality review for management approval.
編寫年度回顧的總結(jié)報(bào)告提交管理層批準(zhǔn).
5. Quality specification and stability studies質(zhì)量標(biāo)準(zhǔn)和穩(wěn)定性研究：
Review quality specification. Ensure the specification compliance with GMP and pharmacopeia requirements
審核質(zhì)量標(biāo)準(zhǔn)，確保標(biāo)準(zhǔn)符合GMP和藥典標(biāo)準(zhǔn)要求。
Be responsible for review analytical method validation.
負(fù)責(zé)審核分析方法學(xué)的驗(yàn)證文件。
Write stability study protocol. Check the implementation of the stability tests on-line.
制訂穩(wěn)定性研究方案。定期跟進(jìn)穩(wěn)定試驗(yàn)進(jìn)度。
6. 驗(yàn)證支持support qualification and validation
Review IQ/OQ/PQ periodical report.
審核IQ/OQ/PQ階段性驗(yàn)證/確認(rèn)報(bào)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(chǎn)品和物料有關(guān)的偏差、變更和OOS調(diào)查文件，確保偏差、變更、OOS對批質(zhì)量無負(fù)面影響。
Implement CAPA action related.
執(zhí)行批放行職責(zé)范圍內(nèi)的CAPA行動(dòng)。
8. Communicate with Zhuhai SFDA負(fù)責(zé)與珠海SFDA的聯(lián)系
Keep communication with city SFDA to response SFDA requirement timely
與市藥監(jiān)部門保持聯(lián)系，及時(shí)回復(fù)藥監(jiān)局的要求。
JOB PROFILE (Education & Experience)
崗位要求 (
學(xué)歷及經(jīng)驗(yàn))
Education 學(xué)歷
Bachelor or above degree of Pharmacy or relative profession.
藥學(xué)/制藥專業(yè)或相關(guān)專業(yè)，本科及本科以上學(xué)歷。
Experience
經(jīng)驗(yàn)
At least five years working experience for drug manufacturing or quality in pharmaceutical enterprises.
五年以上從事藥品生產(chǎn)技術(shù)或質(zhì)量管理工作經(jīng)驗(yàn)。
