Technical Transfer Lead 中山

月薪： 1-1.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 12-22 发布

职位描述

Job PurposeResponsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or o process adaptations.Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.).Main Responsibilities:Launch & Transfer:?Act as Single point of contact on site for technical transfer.?Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.?Provide input into overall project strategy and plans including timelines.?Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions.?Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities.?Ensure that project tracking documentation/tools are up-dated according to plan.?Write Manufacturing Process Transfer Documents (protocol, report).?Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).?Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.?Contribute to inspection (Pre Approval Inspection PAI) readiness.?Contribute to process improvement and optimization for product transfers.Key Performance Indicators?Technical transfer milestones achieved in time and in full. Including schedule for registration and launches.?Robust manufacturing process, delivering critical quality attributes.?Analytical methods in place, meeting cGMP standards.?No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI).?Adheres to project / Capital Approval Request CAR costs.Ideal BackgroundEducation (minimum/desirable):BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.Desirable MSc. or equivalent experience.Languages:Fluent in English and proficient in site local language.Relevant Experiences:?5+ years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience. 职能类别： 医药技术研发人员

联系方式

广东省中山市火炬开发区健康基地辉凌路8号

公司信息

山德士是瑞士诺华集团的子公司，诺华集团是世界第三大制药公司、世界500强企业，是全球唯一在专利药、非专利药、疫苗和非处方药业务上都拥有领导地位的制药公司。诺华集团成立于1996年，由瑞士两家具有百年历史的世界著名制药公司汽巴-嘉基与山德士合并而成。山德士主要从事非专利药品的研发、生产和销售，业务涵盖原料药、制剂和生物制品，拥有950多个化合物和5000多种制剂，是全球第二大非专利药公司。山德士（中国）2007年1月正式开展中国业务，于当年12月20日向德国格兰泰公司收购了位于中山市火炬区健康基地的中山格兰泰制药，并在中山成立了山德士(中国)制药有限公司，注册资金2200万美元，投资总额达3500万美元.

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