莆田招聘

Job Purpose

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

Key Responsibilities

· Ensures all work is conducted in accordance with written procedures in R&D site.

· Responsible for QA systems and processes within R&D (including Change Control Requests, Deviations, Out of Specification and Product Quality Investigations).

· Review and approval/rejection of quality exception documentation (including Change Control Requests, Deviations, Out of Specification and Product Quality Investigations).

· Review and approval/rejection of departmental quality documentation (including SOPS, batch documentation, validation protocols & reports).

· Review and approval of contractor’s quality documentation (batch records, specifications, validation protocols/reports etc).

· Negotiates and establishes Contractor Quality Manuals with all approved contractors

· Prepare and support the R&D department for regulatory inspection and corporate audits

· Responsible for highlighting own training needs and working with manager develop a training plan and achieve training goals.

· Release/rejection of products for pivotal stability or human use.

· Responsible for training system.

· Participate or independently manage internal/external audits

· Represent Quality/Compliance function within R&D projects

· Maintain awareness of regulations impacting areas of work.

· Review, assess, challenge and implement (where appropriate) new/draft regulations.

· Escalation of quality related issues to GSK CH R&D QA manager if resolution cannot be found with NPD Manager.

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.

DIMENSIONS OF THE ROLE:

Basic Requirements

· Bilingual (English/Mandarin).

· Degree in Pharmacy or Chemistry or related areas

· 2-5 years QA experience in the GMP field in Pharmaceutical industry

· Have basic knowledge of GMP regulations (Drug/OTC and/or Medical Device) and practical experience of their application within an R&D environment

· Excellent computer skills - Microsoft applications, electronic quality management applications e.g. LIMS, Training Databases, CAPA Tracking Systems

· Logistic thinking

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.

· Experience in a microbiological laboratory

Behavioral 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

GlaxoSmithkline/葛兰素史克
作为世界领先的制药业巨擘，葛兰素史克公司秉承以研究开发为基础的一贯理念，凭藉公司本身的技术潜力和资源优势，在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司，由葛兰素威康和史克必成强强联合，于2000年12月成立。两家公司的历史均可追溯至19世纪中叶，各自在一个多世纪的不断创新和数次合并中，在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并，为葛兰素史克成为行业中无可争议的领导者奠定了基础，并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国，以美国为业务营运中心，在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平，在疫苗领域雄居行业榜首。此外，公司在消费保健领域也居世界领先地位，主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前，公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化，葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究，目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础（science-driven），通过生物学，化学以及最新技术，创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动，并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
更多信息请访问我们的网站：www.gsk.com or www.gskchina.com