職位描述
新藥質(zhì)量體系管理QCQAGMP認(rèn)證NMPA認(rèn)證
Major tasks & responsibilities:
- Lead the analytical quality assurance for Sun Pharma Biologic product (Drug substance, Drug Product & combination product as required).
- Perform timely review in accordance with the MA and with the approved analytical method of QC analytical data originated at the testing site and timely preparation and issuance of CoAs as requried.
- Act as SME during evaluation and review of product related change controls, deviations, out of specifications, complaints and analytical method validations in regards to analytical testing of inprocess, intermediates and finished products. The QC Manager shall author scientifically sound deviation investigations and assessments and recommends effective corrective actions as appropriate.
- Maintain oversight and management of stability studies executed by the testing labs, including preparation/review of stability protocols, raw data and review/preparation of reports while ensuring proper follow up at the testing site of timely execution of testing plans as per scheduled time points.
- Liaise with external Analytical testing lab for ensuring testing of GMP analytical samples in accordance with approved specifications while maintaining as well oversight of on time testing and execution of stability sample testing.
- Creation, review and maintenance of testing analytical methods and specification ensuring compliance with validation studies and with the marketing authorizations while ensuring proper communication with the testing labs upon receipt or generation of change controls affecting approved analytical methods or relevant specifications.
- Preparation, review and assessment of routine trending of stability data collected for new and annual stability programs and ensuring immediate notification to the Senior QA Manager in case of observed trends or suspected out of specifications.
- Support/author analytical technical assessment as required for supporting deviation investigation or other relevant studies.
- Support the maintenance and update of quality management system related to analytical.
- Support the timely implementation of global and local standards and procedures in the Sun China unit by execution of associated GAPs assessments against localprocedures where required.
- Contribute to the interpretation of regulatory requirements in new or existing Biologics SOP′s.
- Support for the regulatory queries related to analytical topics
- Review & Approve the stability summary sheets.
- Approval of documents related to quality.
- Support technical,attendance & administrative requirement of team members.
Key Performance Indicators/result areas
On time preparation of CoA and on time batch release
- In time management and closure of significant quality events, change controls, complaints, deviations etc.)
- On time receipt and review of stability testing for each time point.Timely issuance of stability testing CoA.
- On time assessment and implementation of Global procedures into QA Biologic QMS.
- On time submission of approved stability studies to Regulatory authorities & others.
- Manage attendance management and other administrative requirement for team members.
Working place: Hangzhou
工作地點(diǎn)
上海市徐匯區(qū)中山西路1800號(hào)4D室
相似職位
- 藥品檢驗(yàn)QA、QC4000-6000元
上海
上海信誼百路達(dá)藥業(yè)有限公司 - QC綜合管理員8000-12000元
上海 - 奉賢
成都邁科康生物科技有限公司 - 制劑生產(chǎn)主管1.3-2萬·14薪
上海 - 浦東
上海艾力斯醫(yī)藥科技股份有限公司 - 醫(yī)藥物流質(zhì)量管理崗1-1.5萬
上海 - 閔行
順豐速運(yùn) - 質(zhì)量部QC（細(xì)胞培養(yǎng)方向）6000-8000元
上海 - 浦東
上海奧浦邁生物科技股份有限公司 - QC專員9000-15000元
上海 - 奉賢
華元(上海)生物醫(yī)藥有限公司
熱門公司推薦
- 霸王茶姬招聘
- 肯德基招聘
- 順豐招聘
- 美團(tuán)招聘
- 京東招聘
- 餓了么招聘
- 比亞迪招聘
- 中國一汽招聘
- 北京汽車招聘
- 蔚來招聘
- 東風(fēng)汽車招聘
- 長城汽車招聘
- 奇瑞汽車招聘
- 理想汽車招聘
- 長鑫存儲(chǔ)招聘
- 天江藥業(yè)招聘
- 藍(lán)月亮招聘
- 安踏招聘
- TCL招聘
- 海信招聘
- 聯(lián)想招聘
- ?？低曊衅?/a>
- 寧德時(shí)代招聘
- 中興招聘
- 新松招聘
- 京東方招聘
- 申通招聘
- 圓通招聘
- 中通招聘
- 百世物流招聘
- 德邦物流招聘
- 麥當(dāng)勞招聘
- 星巴克招聘
- 海底撈招聘
- 蜜雪冰城招聘
- 瑞幸招聘
- 雀巢招聘
- 騰訊招聘
- 百度招聘
- 快手招聘
- 字節(jié)跳動(dòng)招聘
- 新華網(wǎng)招聘
- 小米招聘
- 招商銀行招聘
- 中信銀行招聘
- 北京銀行招聘
- 興業(yè)銀行招聘
- 交通銀行招聘
- 建發(fā)集團(tuán)招聘
- 中國移動(dòng)招聘
- 中國聯(lián)通招聘
- 中國電信招聘
- 中糧集團(tuán)招聘
- 國藥控股招聘
- 中廣核招聘
- 中國船舶招聘
- 強(qiáng)生中國招聘
- 匯豐中國招聘
- 宜家招聘
- 立邦中國招聘
- 伊利招聘
- 青島啤酒招聘
- 京港地鐵招聘
- 寶馬招聘
- 小鵬汽車招聘
- 華為招聘
- 特斯拉招聘
- 吉利招聘
- 奔馳招聘
- 海爾招聘
- 美的招聘
- 京東方招聘
- 施耐德電氣招聘
- 德邦物流招聘
職位發(fā)布者
郭女士/人事
立即溝通
盛發(fā)藥業(yè)(上海)有限公司總公司印度太陽藥業(yè)有限公司（Sunpharma）成立于1983年，是一家在印度股票市值排名第一的跨國制藥企業(yè)，主要生產(chǎn)?？扑幤芳捌湓纤帯Ｎ覀兊奶幏剿幹苿┲饕婕靶难?、中樞神經(jīng)、消化、呼吸等領(lǐng)域以及糖尿病等慢性疾病的治療。我們在所涉足的各個(gè)治療領(lǐng)域均處于領(lǐng)先地位，銷售網(wǎng)絡(luò)覆蓋全球主要市場，包括在美國、歐洲、東南亞、俄羅斯、中東、拉丁美洲、非洲及亞洲等重要的國際市場，其中超過50%的銷售來自于歐美市場。2012和2014年，太陽藥業(yè)被福布斯（Forbes Global）評(píng)選為全球百強(qiáng)最具創(chuàng)新力公司。盛發(fā)藥業(yè)（上海）有限公司是全資子公司，于2020年12月底成立，取代之前的代表處，更好的服務(wù)于中國市場。
公司主頁