南京招聘

Role Purpose：

The purpose of this role is to ensure that materials are received by sites that meet GSK requirements and to complement business initiatives currently being or planned to be implemented within GMS. This is delivered by assessing the GMP compliance and Quality Systems status of suppliers.

Key Accountabilities/Responsibilities：

1. Supplier assessment, approval & compliance

? Perform assessments/audits of suppliers within role scope. Agree corrective and preventive action plans with suppliers and manage to completion. Make proposals about the continued use of suppliers

with marginal compliance.

? Responsible for ensuring that all audit related documents are send out in a timely manner and CAPA related documents are reviewed and responded in a timely manner.

? Responsible for maintenance of supplier profiles in the relevant data systems and ensuring that all data associated with the supplier are current.

? Responsible for regulatory compliance audits of suppliers to ensure that the suppliers are in compliance with GSK”s registered details.

? Responsible for processing change controls and deviations from suppliers in scope as per the current procedures

? Responsible for reviewing regulatory and technical information from suppliers as required ensuring regulatory compliance. This would include but not be limited to

a. Statements regarding animal derived material, genetically modified organisms and Genotoxic impurities

b. Residual solvent and metal levels

c. Supplier status with regard to regulatory inspection

? Responsible to co-ordinate and negotiate with suppliers w.r.t. Quality Assurance Agreements where relevant.

2. Regulatory inspections

Relevant support is provided to GSK sites undergoing regulatory inspections

3. Internal supplier quality processes

? Participate in the development of internal Supplier Quality processes and ensure they meet the requirements of the GSK QMS.

? Responsible to complete all relevant trainings the role requires within the stipulated time frame.

4. Interfaces

Routinely interfaces with Quality and Procurement Commodity teams – a two way communication regarding supplier audit results and impact on materials, components and services delivered to the site.

Qualifications/Requirements:

1. Science degree or experience in pharmaceutical manufacturing and quality operations.

2. Ideally at least 5 years experience in pharmaceutical manufacturing environment

3. Knowledge of regulatory, GMP and GSK quality requirements and ability to explain these and relate to GMS and supplier operations, applying good business judgment in doing so.

4. Proficiency and experience in planning and executing audits to identify and reduce significant risks / non-compliances.

5. Awareness of business environment and ability to build networks with third party suppliers

6. Good influencing and negotiating skills to ensure implementation of appropriate standards, specifications and agreements.

7. Good verbal and written communications skills to ensure effective relay of issues, risks and opportunities so that these are well understood by all parties and that effective actions are put in place.

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。
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