AS&T Facilitator 苏州

月薪： 1.5-2万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Job Purpose：This role is responsible for managing AS&T group* to achieve excellence in analytical areas through competent and capable staff and state-of-the-art equipment, technologies and procedures and to support ChemOps SNPT products lifecycle approach.Specifically, this role is responsible for method validation/verification, transfers, troubleshooting continuous improvements and Stability Study (re-test period verification), served as the stability and method study liaison between Quality Control, TR&D and Quality Assurance. This role is also responsible for process performance characterization (incl. raw materials) together with MS&T including reviewing and approving protocols and reports for method validation, cleaning validation and stability study. In addition, this role will ensure statistics and statistical decision making. Plus, this role is responsible for lab design and lab capital investment strategy.* Note: no direct reports (in SAP)Major Accountabilities：?Ensure that all analytical activities are performed according to the local Quality system and SOP’s.?Ensure that all aspects of lab operational business comply with cGMP, legal and regulatory requirements and with the Novartis Pharma Corporate Quality Manual and Policies.?Ensure method validation/verification and activities relevant to method transfer into/out site are aligned with site strategy.?Evaluation and introduction of new technologies.?Centralized investigation support / troubleshooting incl. complaints investigations.?Contribute for qualification of contract laboratories.?Administration of the stability program (re-test period verification) incl. tracking the performance of stability test plan adherence rate. Ensure stability samples are tested according to regulation requirements.?Technology Implementation incl. support of QbD/PAT.?Responsible for QM master data management.?Support the development and/or improvement of existing analytical test methods used in the Quality Control Laboratories.?Based on requests from Quality Control Laboratories, review and evaluate proposed changes in local, global and pharmacopoeia test procedures that impact on the laboratory and to provide input to product analytical documents.?Provide analytical testing and sampling support for production equipment cleaning validation activities.?Analysis process performance characterization (incl. raw materials) together with MS&T.?Responsible for lab design and lab capital investment strategy?Make decision based on statistics and statistically.?Perform integrated planning, priority setting and execution of activities fully synchronized with the Production Process Units and the Quality Process Units.?Supports multiple teams and projects, requiring excellent coordination of priority setting with constant feedback on progress.?Provide leadership, direction and support to the analytical service team and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.?Support and coordinate Laboratories’ HSE.Key Performance Indicators：?Meets established project/action plan timelines.?Meets or exceeds customer (i.e. QC-Testing, Compliance, Technical Support, Demand Management) expectations.?Meets cGMP analytical testing record archive expectations?Internal Investigation cycle time?Customer Service Levels?The number and severity of cGMP issues identified during internal and external auditsBackground：Education(minimum/desirable:MS/BS Degree in a scientific disciplineLanguages:Local language, English reading and understanding.        Experience:？5+ years experience in a Pharmaceutical Development or Quality Control laboratory environment, including 2+ years supervisory experience.？ 职能类别： 药品生产/质量管理

联系方式

苏州

公司信息

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。 “诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。 诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。

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