北京招聘

Key Accountabilities/Responsibilities:

· To undergo training in GQP 1101 and GQMP&G 1003 on Effective QMS Implementation.
· Responsible for the QMS (Quality Management System) implementation and monitoring of compliance within the China Cx LOC(China Local Operating Company)/ Marketing Company by:
a. Implementing and maintaining effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, Guide for Commercial Companies etc.
b. Ensuring there is a QMS input into the main aspects of the LOC operations that influence product quality.
c. Manage the preparation and conduct of L3/L4 audits of the LOC.
· Ensuring that all colleagues in the LOC are adequately trained on the procedures and processes that relate to QMS.
· Ensure the QMS implementation is lean as well as compliant and activities are conducted to ensure sustainability by adopting the principles of OE.
· To identify resource capable of performing gap analyses of LOC or global SOPs, Corporate Policies (as they apply to LOC Quality) and the QMS updates.
· To ensure gap analyses are conducted& to ensure risks associated with gaps are assessed.
· To ensure action plans to address risks are established in accordance with GQMP 1003 specified timelines.
· To escalate significant QMS risks and issues related to QMS implementation.
· To provide regular reports on progress against gap closure action plan and ongoing QMS 'in place' and 'in use' performance, for LOC and Regional review.
· To ensure training needs are assessed for target groups and plans for training are prepared for closed gaps and in advance of receipt of new or revised QMS documents.
· To notify relevant LOC teams and other impacted target groups of new or revised QMS documents.
· To act as the principle point of contact between the Central QMS Team and the LOC for effective communication of existing, new or revised QMS requirements.

Qualifications/Requirements:

· Graduate (or equivalent) qualification with at least 10 years post qualification experience in the pharmaceutical or allied industry.
· Experienced in handling regulatory interfaces such as inspections.
· Detailed knowledge of the GSK Quality Management System.
· Able to demonstrate experience of working effectively with diverse teams of professional staff.
· Leadership and team working skills.

中美天津史克制药有限公司是全球***的制药企业之一的葛兰素史克(GSK)与国内大型制药企业天津中新药业股份有限公司和天津太平(集团)有限公司共同投资设立的制药企业。

作为***在华设立的外商合资制药企业之一，中美史克早在1987年便在中国生根。20年来，中美史克一直秉承着大爱铭心的理念，用优质的产品和爱心回报社会。2008年，中美史克家族除了消费者耳熟能详的四大OTC品牌新康泰克、芬必得、百多邦、史克肠虫清外，还成功上市了全球牙医首选推荐的抗牙敏感牙膏舒适达； 新康泰克和芬必得两大品牌家族又添新成员，2008年，新康泰克红色重感装成功上市；2009年，芬必得酚咖片新头痛装的成功上市，中美史克将更好地呵护人们的健康生活。

中美史克注重以人为本，有着激动人心的“3T”企业文化。2007年开始推行的“3T”文化经过一年来的渗透，在2008年更加深入人心。
相互信任(Trust)、开放透明(Transparent)、积极主动 (Take initiative)的“3T企业文化”如今已成为史克员工日常的工作方式，引领着员工与企业共同成长。