職位描述
POSITION SUMMARY（職位概述）
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
確保產(chǎn)品質(zhì)量控制活動(dòng)遵循了質(zhì)量管理體系、產(chǎn)品規(guī)范、生產(chǎn)工藝、控制計(jì)劃的要求，并且應(yīng)用恰當(dāng)?shù)馁|(zhì)量分析工具。
KEY RESPONSIBILITIES（主要職責(zé)）
Production process management: check the quality control point for each key production steps, check the line clearance and cleaning results. Responsible for release of bulk product.
生產(chǎn)過(guò)程管理：對(duì)每批產(chǎn)品生產(chǎn)各環(huán)節(jié)的質(zhì)量控制點(diǎn)進(jìn)行檢查， 對(duì)車(chē)間清場(chǎng)、清潔結(jié)果進(jìn)行檢查。負(fù)責(zé)車(chē)間半成品的放行。
Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
審核到貨檢驗(yàn)結(jié)果。審核批生產(chǎn)記錄和批檢驗(yàn)記錄。
Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
參入質(zhì)量事件/偏差/ CAPA的根本原因調(diào)查和措施跟蹤，參入變更控制的評(píng)估流程和行動(dòng)的跟蹤。
Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
審核驗(yàn)證方案和驗(yàn)證報(bào)告。在驗(yàn)證執(zhí)行過(guò)程中負(fù)責(zé)取樣并監(jiān)督驗(yàn)證的執(zhí)行。
Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草質(zhì)量保證相關(guān)流程。領(lǐng)導(dǎo)建立控制計(jì)劃、P-FMEA、質(zhì)量計(jì)劃等文件。
Responsible for sampling for product, retention sample and periodic inspection
負(fù)責(zé)車(chē)間取樣、留樣產(chǎn)品和周期檢驗(yàn)。
Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
參入供應(yīng)商管理，包括供應(yīng)商初始確認(rèn)評(píng)估、現(xiàn)場(chǎng)審計(jì)、供應(yīng)商績(jī)效評(píng)估、供應(yīng)商投訴等。
Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生產(chǎn)部工程師對(duì)客戶(hù)投訴進(jìn)行調(diào)查，并審核調(diào)查報(bào)告及措施，精確解決客戶(hù)投訴。
Aware to national standard/regulation requirements of products for driving product compliance.
了解國(guó)家標(biāo)準(zhǔn)和法規(guī)要求并推動(dòng)產(chǎn)品符合相應(yīng)的要求。
EHS compliance in the responsible area
負(fù)責(zé)區(qū)域的EHS合規(guī)。
Other superior assigned work
上級(jí)指派其它的工作。
SKILLS AND ABILITIES（技能）
Bachelor degree or above in the major of pharmaceutical technical relevant
本科或以上學(xué)歷畢業(yè)，藥學(xué)相關(guān)專(zhuān)業(yè)
At least 3 years relevant work experience of QA engineers or supervisors in pharmaceutical companies
至少3年以上醫(yī)藥企業(yè)QA工程師或主管的相關(guān)工作經(jīng)驗(yàn)
Be familiar with relevant regulation requirements for drug, drug GMP requirements; medical device GMP/ISO 13485 requirements
熟悉國(guó)家有關(guān)的藥品的法規(guī)、熟悉藥品GMP要求、熟悉醫(yī)療器械GMP/ISO 13485要求。
team player with well communicative and cooperative,
具有良好溝通和協(xié)作能力的團(tuán)隊(duì)成員
Fluent in listening and speaking in English and Chinese
中英文聽(tīng)說(shuō)讀寫(xiě)流利；
企業(yè)簡(jiǎn)介
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
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