杭州招聘

Responsible for the Commercial QA activities of the country for Teva products, including but not limited to Branded/Specialty, Generics, Branded Generics and Biosimilars.
? Responsible for the quality operational implementation in Greater China including product quality release and product quality complaint
? Ensure operational implementation of Quality Management System in compliance with GMP&GDP, Teva Corporate and International Markets Standards, and national regulations
? Primary company contact with local Health Authorities in relation to GMP/GDP inspections, quality incidents and recalls in China
? Responsible for quality oversight and regulatory compliance of products marketed in China
? Support the APAC Commercial Quality Head for rolling out of Teva Quality Management System at the commercial unit (including Teva owned local warehouse)
? Support APAC Commercial Quality head on quality approval and management of local 3rd party service providers/ suppliers/ manufacturers/ distributors.
? Support APAC Commercial Quality on any critical quality incident
? Rolling out of Teva Quality Management System
o Create, maintain up-to-date and distribute Standard. Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations.
o Ensure GMP & GDP compliance at the commercial unit and promote the quality culture.
o Support GMP and GDP training at a local level.
o Support continuous improvement of processes.
o Ensure a system is in place to manage and review Product Quality Reviews for imported products.
o Attend and support quarterly quality councils.
o Provide monthly quality metrics.
? Operational implementation of Quality Management system
? Market release
o Ensure the market release from approved suppliers based on batch release documentation and transport conditions documentation.

Key accountabilities:
? Rolling out of Teva Quality Management System
o Create, maintain up-to-date and distribute Standard. Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations.
o Ensure GMP & GDP compliance at the commercial unit and promote the quality culture.
o Support GMP and GDP training at a local level.
o Support continuous improvement of processes.
o Ensure a system is in place to manage and review Product Quality Reviews for imported products.
o Attend and support quarterly quality councils.
o Provide monthly quality metrics.
? Operational implementation of Quality Management system
? Market release
o Ensure the market release from approved suppliers based on batch release documentation and transport conditions documentation.
o Ensure the distribution traceability of finished products and returns of products commercialized in the country.
? Distribution
o Ensure the GDP compliance of the distribution centers.
? Complaints and Recalls
o Ensure that quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary.
o In case of recall ensure the local coordination between PhV, medical affairs, regulatory affairs, supply chain, etc. and with sit Quality Head/ EU Qualified person concerned. Escalate any critical information to sub regional head of commercial quality and issue the final recall report.
? Change control, deviations and CAPAs
o Administer, maintain and develop systems for change control, and deviation and CAPA handling.
? Distributors, Suppliers/manufacturers and other 3rd party service providers
o Maintain, monitor and approve a list of approved 3rd parties.
o Ensure that Quality Agreements are drawn up and kept updated with all local distributors, suppliers/ manufacturers and 3rd party service providers as required.
? Archiving
o Ensure that relevant quality related documentation is archived as required.
? Report critical quality incidents to Management
o Report to Regional Quality and local management any critical quality incident.
? Authority inspections and audits
o Host and lead GMP/GDP related competent authority inspections.
o Perform or coordinate internal audits of the compliance of the Quality System.
o Perform or coordinate external audits, with respect to quality related matters, of local warehouses/distributors and other local suppliers/service providers as per Teva standards.
? Internal and External Relations
o Set up and maintain contacts with local general manager, RA, drug safety officer, medical manager, launches manager, Quality personnel at the Teva and 3rd party manufacturing/batch release sites, local distributors and other relevant companies.

任职要求：
? Degree in Pharmaceutical Sciences, Healthcare or an equivalent combination of education and experience for the functional role.
? Minimum of 2 years experience as a quality personnel in a pharmaceutical company or importer/distributor. 4+ years experience preferred.
? Demonstrated knowledge and working experience with PIC/S GMP and GSP/GDP and government regulations for China
? Fluently in written and spoken English
? Ability to clearly and effectively communicate with all levels in the organization as well as with Health Authorities

Teva 是一家总部位于以色列的全球性医药公司，是全世界***的“药柜”，拥有超过1,800个分子化合物，35,000个产品。我们的使命是成为全球仿制药和生物制药的领导者，提高和改善病患的生活质量。目前Teva在全球共有43,000名员工，在近60个国家开展业务，2018年全年销售额接近190亿美金。现在Teva已经来到中国，作为全球使命的一部分，Teva 中国将会在未来的几年里大力拓展本土业务， 上市我们创新研发的原研药品，以高品质药品为中国数百万患者提供帮助。在未来，Teva承诺会为中国的病患，以更快的速度带来更新更好的药物。