北京招聘

1. JOB PURPOSE
?To ensure that the QMS is implemented and sustained locally.
?Establish a network of personnel to handle implementation of new and revised GQPs and GQMPs.
?Accountable and this network collectively responsible, for implementing QMS requirements within the local quality system and supporting its continual improvement.
?To take the lead in implementing and sustaining the QMS in the China Cx LOC, including encouraging the Commercial Cx business to own quality activities in their day to day work.

2. PRINCIPLE ACCOUNTABILITIES

? 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/ 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 , Chinese Good Quality Practice and regulatory requirements by performing the following:
1.？Ensuring that all SOPs are in place, updated & training has been conducted
2.？Promoting QMS management principles and seek continuous improvement of the processes
3.？Managing QMS Management Review meetings according to local SOPs.
4.？Identifying, implementing and managing QA Objectives & KPIs
5.？Establishing and managing Annual Quality Plans as they apply to the QMS
6.？Ensuring that all internal procedures and systems in use in the LOC are compliant to GSK QMS , Guide for Commercial Companies and local regulatory requirements, including (but not limited to)
a.QMS Structure, Content, Management and Deployment
b.Artwork process
c.Change Control (including regulatory change ensuring ongoing compliance to registered details)
d.Complaint handling, trending and escalation
e.Batch disposition
f.Product Quality Review
g.Risk Management
h.Q Plan generation and execution
i.Documentation system (SOPs)
j.Training
k.Distribution
l.Repacking
m.Management of Product Incidents and Recalls
n.Technical Terms of Supply
o.Auditing (Level 1&2)
p.Deviation Management
q.Corrective and Preventive Action

B.Monitoring and assessing quality systems by means of audit and self-inspection, and other forms of evaluation against GSK standards, GQPs, GMP and regulatory requirements:
？1.Conducting self, cross functional audits
？2.Reviewing internal audit findings with the aim of measuring the ongoing effectiveness of the in use implementation of the QMS.
C. Ensuring there is a QMS input into the main aspects of the LOC operations that influence product quality.
D. 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.
?To ensure a robust mechanism for sustaining conformance of the local quality system with QMS requirements has been established and remains effective.
?To ensure local audit processes build in routine assessments of QMS ‘in place’ and ‘in use’ status.
?To share and publicise achievements and QMS implementation successes, recognising and rewarding individuals and teams as appropriate.
?Provide QMS advice on an ongoing basis, as required.
?Promote safety awareness.
?To use the resources of the LOC to ensure compliance and efficient performance is maintained.

3. SKILLS AND EXPERIENCE
1.Graduate (or equivalent) qualification with at least 10 years post qualification experience in the pharmaceutical or allied industry.
2.Experienced in handling regulatory interfaces such as inspections.
3.Detailed knowledge of the GSK Quality Management System.
4.Able to demonstrate experience of working effectively with diverse teams of professional staff.
5.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。