400-885-9898
职位描述
新药质量体系管理QCQAGMP认证NMPA认证
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
Mandatory
• BSc in Bio chemistry/biotechnology of pharmaceutical field.
Preferred
• BSc. In biotechnology/biochemistry
- 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.
Mandatory
• BSc in Bio chemistry/biotechnology of pharmaceutical field.
Preferred
• BSc. In biotechnology/biochemistry
Working place: Hangzhou
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工作地点
上海市徐汇区中山西路1800号4D室
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职位发布者
郭女士/人事
立即沟通
盛发药业(上海)有限公司总公司印度太阳药业有限公司（Sunpharma）成立于1983年，是一家在印度股票市值排名第一的跨国制药企业，主要生产专科药品及其原料药。我们的处方药制剂主要涉及心血管、中枢神经、消化、呼吸等领域以及糖尿病等慢性疾病的治疗。我们在所涉足的各个治疗领域均处于领先地位，销售网络覆盖全球主要市场，包括在美国、欧洲、东南亚、俄罗斯、中东、拉丁美洲、非洲及亚洲等重要的国际市场，其中超过50%的销售来自于欧美市场。2012和2014年，太阳药业被福布斯（Forbes Global）评选为全球百强最具创新力公司。盛发药业（上海）有限公司是全资子公司，于2020年12月底成立，取代之前的代表处，更好的服务于中国市场。
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