職位描述
QA審核QA認證生物藥
Overall Job Purpose:
? The QA CMO Supervisor is responsible for ensuring compliance in Sun Pharma’s biological product manufactured externally. This includes supporting the QA Manager CMO Biologics on Quality System development (license B application readiness), commercial operations, in addition to on-time release of product and appropriate maintenance of local quality systems. He/she ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement. Supports in the maintenance of the QMS to align with Health Authority Regulations.
Major tasks & responsibilities:
? Support the creation and maintenance of Quality Systems required for license B application readiness.
? Supports the interpretation of regulatory requirements in to SOP′s
? Support the timely implementation of global standards and procedures in to the local QMS which may involve execution of gap assessments against local procedures.
? Manages (Initiates, investigates and ensures timely closures) key quality systems and product related deviations, change controls, CAPAs, complaints by liaising with CMO’s and other Sun stakeholders.
? Assess, based on risk management tools and thorough and good understanding of manufacturing operations, change controls, deviations and complaints while ensuring proper implementation in marketing authorizations of changes proposed by different stakeholders.
? Manages and maintain product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release.
? Review of batch documentation in preparation for batch release and to ensure compliance with GMP and with the marketing authorizations
? Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required.
? Preparation of annual product reviews (APR/PQR).
? Support planning and execution of external and internal audits
Key Performance Indicators/result areas
? License B Application readiness
? On time batch release
? First time right of batch documentation review
? In time management and closure of significant quality events, change controls, complaints, deviations etc.
? On time preparation of APR/PQR.
? On time support of new projects.
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate) Mandatory
? Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
? Minimum of 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
? Strong knowledge of Chinese GMP, EU GMP, US CFRs.
? Well versed in Microsoft Excel.
? Competency in English
Preferred:
? MSc on (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
? The QA CMO Supervisor is responsible for ensuring compliance in Sun Pharma’s biological product manufactured externally. This includes supporting the QA Manager CMO Biologics on Quality System development (license B application readiness), commercial operations, in addition to on-time release of product and appropriate maintenance of local quality systems. He/she ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement. Supports in the maintenance of the QMS to align with Health Authority Regulations.
Major tasks & responsibilities:
? Support the creation and maintenance of Quality Systems required for license B application readiness.
? Supports the interpretation of regulatory requirements in to SOP′s
? Support the timely implementation of global standards and procedures in to the local QMS which may involve execution of gap assessments against local procedures.
? Manages (Initiates, investigates and ensures timely closures) key quality systems and product related deviations, change controls, CAPAs, complaints by liaising with CMO’s and other Sun stakeholders.
? Assess, based on risk management tools and thorough and good understanding of manufacturing operations, change controls, deviations and complaints while ensuring proper implementation in marketing authorizations of changes proposed by different stakeholders.
? Manages and maintain product specification in accordance with current marketing authorizations and ensure timely updated of applicable associated documentation in support for batch release.
? Review of batch documentation in preparation for batch release and to ensure compliance with GMP and with the marketing authorizations
? Supports technology transfers and process/ analytical method validation activities from quality operations perspective when required.
? Preparation of annual product reviews (APR/PQR).
? Support planning and execution of external and internal audits
Key Performance Indicators/result areas
? License B Application readiness
? On time batch release
? First time right of batch documentation review
? In time management and closure of significant quality events, change controls, complaints, deviations etc.
? On time preparation of APR/PQR.
? On time support of new projects.
Qualifications, Knowledge, Experience & Skills
Education Qualifications (Graduate- Post Graduate) Mandatory
? Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
? Minimum of 5 years of relevant experience in (bio) pharmaceutical Drug Substance and/or Drug Product manufacturing.
? Strong knowledge of Chinese GMP, EU GMP, US CFRs.
? Well versed in Microsoft Excel.
? Competency in English
Preferred:
? MSc on (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
工作地點
秀英區(qū)?？谒幑壬镝t(yī)藥創(chuàng)新綜合體
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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）評選為全球百強最具創(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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