上海招聘

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

Qualification & Requirements
· At least 8 years of working experience within the pharmaceutical industry
· Graduation in sciences (e.g. chemist, pharmacist, biologist) or similar education
· Experience of at least 5 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
· Very good organisational 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
MS Office (e.g. Word; Excel …)

Reporting to & Supervision by
Director Corporate Quality Management
五险一金，出差补贴，每年有旅游安排,有额外年假15-20天

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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.