上海相关职位： 大分子疫苗GMP规范实验室技术员 ***医学实验设计 骨科医疗器械生产主管 C/C++高级开发工程师 3D算法工程师 C/C++高级开发工程师 医学图像软件工程师 OpenGL工程师 医学图像算法工程师 开发肝脏分割算法工程师
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-12-12
-
5-7年经验 -
本科 -
招1人 -
01-26 发布
- 五险一金
- 补充医疗保险
- 补充公积金
- 员工旅游
- 通讯补贴
- 专业培训
- 年终奖金
- 出国机会
- 弹性工作
- 定期体检
职位描述
Key Responsibilities ·Ensuring that international (focus = EU & US markets) GxP and regulatory standards are followed during sourcing, development, procurement, manufacturing and supply chain activities of starting materials and medicinal products·Participation in and coordination of QM activities and GxP related support in inter-divisional, Midas Pharma group-wide and / or cross-company projects ·Supplier Qualification including documentation, coordination and follow-up of supplier and product documentation such as (but not limited to) Drug Master Files, Dossiers, Site Master Files, Validation documents. Communication with the manufacturing and development partners and reviewing, advising and compiling of GxP and regulatory relevant documents and certificates·Product Life Cycle including registration, coordination, evaluation and follow-up of Changes, Non-conformities which appear in the framework of internal as well as external established processes·Support of an effective functioning of the Corporate Quality Management Division·Support on the authority inspection with English interpretation. ·Experiences with EHS evaluation of the business partnersQualification & Requirements ·At least 5 years of working experience within the pharmaceutical industry·Graduation in sciences (e.g. chemist, pharmacist, biologist) or similar education·Experience of at least 2 years in Quality Management aspects (e. g. Auditing, Project Management)·Excellent knowledge of national and international pharmaceutical guidelines (e. g. EU GMP Parts, WHO-Guidelines, ICH-Guidelines, US FDA, etc.)·Willingness to travel on regular basis·Fluent level of English, both spoken and written·Good organizational skills with the ability to prioritizing workload and managing time efficiently·Experience in working in cross-functional project teams·Flexibility and ability to work in fast developing environment·Good communication and execution skills as well as intercultural competence·EHS knowledge and experiences is preferable·MS Office (e.g. Word; Excel ; PPT…) Reporting to & Supervision by MPC Head of QM China / Director Corporate Quality Management 职能类别： 药品生产/质量管理
联系方式
虹桥路2272号虹桥商务大厦4楼O室
公司信息
Being a marketing and sales company, we provide multiple services to the pharmaceutical companies. Our objective is to be the partner of first choice for Active Pharmaceutical Ingredients, Custom Synthesis, International Licensing or Registration Dossiers. Our office in Shanghai selects, for the Group and its customers, reliable Chinese partners for Active Pharmaceutical Ingredients, Intermediates and Finished Dosage Forms. To our Chinese partners we provide regulatory support, GMP-consultancy and market intelligence.
