长沙招聘

职位描述：
Responsibility:
I QA - China
? Establish the quality management system, guide and supervise the implementation of the system, maintain and improve on the system documentation
? Collect the laws and regulations on medical device operation and supervision, file management of the regulations, supervise the implementation of laws and regulations
? Examine the production and/or operation qualifications of suppliers (suppliers of products, suppliers of services)
? Examine the qualification documents of importer, 3rd party logistics, distributors and sub-distributors
? Perform on-site inspection to importer and 3rd party logistics per quarter
? Identify unqualified medical devices and supervise their disposal process
? Collect, investigate and report quality complaints and quality incidents
? Collect, investigate and report adverse events
? Manage product recalls
? Develop and implement efficient procedures that effectively promote compliance, analyzing quality data and results on an ongoing basis to identify quality issues and trends.
? Promptly and proactively communicate issues and initiating actions to drive continuous improvement; reporting and escalating issues to management as per applicable policies
? Creating and maintaining accurate inspection-ready records, files, and reports to conform to policies, procedures, good documentation practices, regulations and quality standards
? Organize quality management training
? Manage self-assessment as well as inspections by Health Authorities
? Manage the post-market surveillance of medical devices, OTC drugs, health foods and cosmetics for China (coordination with HQ and HCP)

II Quality Management of the Finished Good Suppliers
? Manages the quality aspects in the development, sourcing and supply of products with Chinese purchaser in Asia (China and South Eastern Asia)
o Audits of the supplier and/or subcontractor
o Follow-up of the corrective action plans
o Implementation and maintenance of the quality agreement and technical specifications for Asian countries
o Assistance of Mother Companies for development and maintenance of quality agreements and technical specifications for Mother Companies’ products manufactured by these suppliers
? Development of a table for follow up of these suppliers and KPI for reporting to Asia QA/RA Manager, and Quality Head of Mother Companies
? Implementation of practices for qualification of suppliers located in Asia (China and South Eastern Asia)

Required skills and competencies:
? Key technical skills
o Knowledge of the ISO 13485, GMP, and MDD93/42 EEC, MMD2007/47 Quality Systems
o Fundamental knowledge of the regulatory requirements for Medical Devices (priority), drugs, dietary supplements, cosmetics.
o University degree from Pharmacy, Biology, Chemistry and Chemical engineering.
? Minimum 5 years of experience in the field of medical devices or pharmacy
? Good knowledge of regulations, experience in quality systems and clinical studies will be appreciated
? Key behavior skills
o Rigor, preciseness
o Dynamism, social and relation skills
o Leadership
o Self-driven
? Cross-cultural abilities
? Language: English mandatory 举报 分享

公司网址：www.urgo.cn

全球简介

法国优格集团公司（VIVA SANTE）是一家历史悠久的跨国集团公司，创立于1890年。历经了120多年，专业从事伤口愈合、外科敷料、皮肤护理及非处方药品。创新和全球化引领公司不断成长。VIVA SANTE集团于1998年进入中国市场。独有的脂质水胶专利技术（TLC）使换药无痛，促进伤口愈合。VIVA SANTE公司的科学家团队由化学家、聚合物专家、医师、工艺师、生物学家和药学家组成，致力于推动活性物质和智能材料的前沿研究。
 优格的业务
 
优格公司的产品行销80多个国家，在全球9个国家设立分支机构和销售代表处。公司提倡多元文化，严控产品安全，严格进行的临床研究与评估。自1997年以来开展了55个临床试验，入选2500名患者进行了30000例观察性研究。VIVA SANTE公司的使命是为中国的医务工作者和患者提供高质量的革新产品及完善的专业售后服务。我们的宗旨是成为中国医疗保健领域的主要战略伙伴，高瞻远瞩，回报社会。