长沙招聘

职位目的
To assure the quality of all products developed, manufactured and released within, or on behalf of, GSK CHRD, China.

主要工作职责
Quality Assurance:-
• Ensures GSK Quality Management System GMP requirements are implemented at all contractors conducting work for and on behalf of GSKCH R&D. Applicable GMPs would include those governing medicinal, medical device, cosmetic, food and dietary supplement products.
• Review and approval of contractor’s quality documentation (batch records, specifications, validation protocols/reports etc).
• Final review and approval of R&D batches for human use (including clinical trials)
• Negotiates and establishes Contractor Quality Manuals with all approved contractors.
Regulatory Compliance:-
• Assists in conducting initial supplier approval audits.
• Maintains awareness of the most current practice of industry that is applicable to GSKCH R&D and shares best practices with key functional areas.
General:-
• Advises contractors on GMP and Quality Management System requirements on an on-going basis and also in helping remediate non-compliances.
• Provides local training in GMP and SOPs.
• Generates and reports metrics data to demonstrate on-going acceptability of GMP activities and to identify any adverse trends.
• Identifies, submits for approval and manages continuous improvement initiatives within area of expertise.
• Represents QCM on assigned project teams.

申请资格
Basic Requirements
• Bilingual (English/Mandarin).
• Degree in a science-related discipline or equivalent QA/analytical/microbiological/clinical experience
• Thorough understanding of GMP regulations (Drug/OTC and/or Medical Device) and practical experience of their application within an R&D environment
• Experience of conducting and/or participating in internal and/or external (including Regulatory Authority) audits.
• Excellent computer skills - Microsoft applications, electronic quality management applications e.g. LIMS, Training Databases, CAPA Tracking Systems Preferred Skills
• Good understanding of GMPs for Cosmetics, Foods and Dietary Supplements.
• Good understanding of general quality management principles e.g. ISO9001, Total Quality, Lean Sigma, Operational Excellence and practical experience of implementing effective quality procedures.
• Demonstrable experience of raw material/batch release, review and approval of validation documentation (equipment/methods/systems), writing quality procedures.
• Good understanding of ICH requirements.
• Experience of working with a network of contractors.
• Knowledge of stability studies and shelf life prediction using statistical analysis. Behavioural Requirements
• CONTRIBUTING TO TEAM SUCCESS - Good team player – actively participates in assigned project teams; offers timely advice on quality requirements; monitors progress and supports alternate compliant strategies • DECISION MAKING - Good decision making and problem resolution – able to understand quality-related issues from project teams, find solutions to problems; monitor progress
• QUALITY ORIENTATION - Good communicator in written and oral form – able to clearly communicate quality requirements to contractors and project teams; write concise and effective communications and Contractor Quality Manuals and training materials as appropriate
• MANAGING WORK - Well organized and adaptable – able to work with multiple contractors and/or project teams; able to prioritise work to meet project/business needs; able to adjust priorities when appropriate; able to handle stressful situations/conflict and work well under pressure.
• INNOVATION - Generating innovative solutions in work situations. Trying different and novel ways to deal with work problems and opportunities. Proactively seeks alternative, compliant ways of working in varying circumstances

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。