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更新于 2月21日

QA CMO Manager Biologics

2-4萬·13薪
  • 上海徐匯區(qū)
  • 10年以上
  • 本科
  • 全職
  • 招1人

職位描述

QA認(rèn)證QA審核QA檢驗(yàn)
Major Responsibilities: Management of weekly QA batch release planning of Biologic products Review of batch documentation in preparation of batch certification by QP to ensure compliance with GMP and with the marketing authorizations as well applicable and correct documentation for release (CoA, CoC etc.) Management (Initiates, investigates and ensures timely closures) of key quality systems including deviations, change controls, CAPAs, complaints associated with the products, by liaising with CMOs, QA Manager/QP , operations, QC and other Sun stakeholders associated with Drug Substance/API , Drug Products or Medical Devices appropriately and in a timely fashion. Lead and organize periodic quality meetings to evaluate the status and timely closing of Change Controls, Deviations, and CAPAS with CMOs, internal departments (QP, Supply Chain and RA), process and product-related. Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required. Preparation of annual product reviews (APR/PQR) of Biologics products Manages and maintains product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release. Review, prepare batch document for QP Batch release of clinical trial batches, and ensures proper maintenance of product specification files to ensure compliance with INDs and IMPDs. Responsible for receiving, managing, and tracking CMO change notification; performing timely communication with both internal and external internal stakeholders according to the requirements of Quality Agreements. Ensures the comprehensive use of risk management tools in aspects across the quality management system, and product related elements to assess impact on product quality, and overall compliance with regulatory expectations and with the marketing authorizations. Works closely together with the Quality System Manager to support the QA IT systems and acts as a back-up for QA IT systems activities. Support the timely implementation of global standards and procedures by execution of associated GAP assessments against local procedures. Support the maintenance and update of Quality Management System. Support planning and inspection readiness for external audits (from partners, Corporate Quality Systems and regulatory authorities Education Qualifications (Graduate- Post Graduate) Mandatory HBO or Bachelor Degree in (Bio-)Chemistry, Pharmacy, Biotechnology or similar education. Minimum of 8 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing. Strong knowledge of EU GMP, US CFRs Well versed in Microsoft Excel. Fluent in English Work experience Mandatory Tenure: minimum 8 years Industry: (Bio) pharmaceutical, sterile manufacturing Content areas: Manufacturing, QA/QC, QA operations. *Working Place is designated by the company

工作地點(diǎn)

上海市徐匯區(qū)中山西路1800號(hào)4D室

職位發(fā)布者

郭女士/人事

昨日活躍
立即溝通
公司Logo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?cè)谒孀愕母鱾€(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。
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