職位描述
新藥質量體系管理QCQAGMP認證NMPA認證
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
上海市徐匯區中山西路1800號4D室
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職位發布者
郭女士/人事
昨日活躍立即溝通
盛發藥業(上海)有限公司總公司印度太陽藥業有限公司（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，主要生產專科藥品及其原料藥。我們的處方藥制劑主要涉及心血管、中樞神經、消化、呼吸等領域以及糖尿病等慢性疾病的治療。我們在所涉足的各個治療領域均處于領先地位，銷售網絡覆蓋全球主要市場，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，太陽藥業被福布斯（Forbes Global）評選為全球百強最具創新力公司。盛發藥業（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，更好的服務于中國市場。
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