南京招聘

Job Purpose and Key Responsibilities:

Job Purpose :

To ensure that all validation work is conducted and fully documented to meet Corporate and local requirements. Supervise and coordinate the implementation of validation activities by individual departments.　　

Key Responsibilities岗位描述:

1. Improve and standardize validation process against GMP, GQP & GQMP, perform gap analysis reports, establish action plan and prepare SOPs.

2. Routinely update site master validation plan.

3. According to the site master validation plan to coordinate the validation, revalidation, validation review and change control assessment for facility/production equipment/process/lab instrument/cleaning process.

4. Ensure compliance with internal and external computerised system policies and regulations.

5. Organise/Co-ordinate site for computerised system validation activities.

6. Monitor/support on-going computer compliance.

7. Assist in/lead annual quality improvement projects. Assist in TT & NPI projects and validation/trial practice to ensure quality system in use during these implementations.

8. Numbering and arching the validation documentation. Timely update and backup the list for validation documents. Keep the documentation orderly without lost and archive timely before handover to documentation administrator.

9. Participate in relevant file preparation, such as annual product review and manufacturing deviation/investigation, analyze the tendency of product quality and raise the proposals to ensure that the product quality will be improved.

10. Be responsible for maintenance of Change control management system, coordinate change related projects or activities and change review meetings periodically. Be responsible for archiving and sorting of change control documents. Be responsible for following up implementation action & CAPA.

11. Perform self inspection as required and follow up, and ensure the action be taken timely

12. Participate in handling of customer complaints as appropriate

13. Obey the safe policy of company.

14. Carry out other works arranged by Validation supervisor

Specialised Knowledge:

¨ breadth & depth across disciplines or functions; expertise in field required education degree and speciality

Bachelor degree or above, prefer major in pharmaceutics or related.

·working experience

More than 3 years validation experiences

· speciality knowledge/skill

Prefer to know relative state and regional law, such as GMP,GLP

Prefer to be familiar with all company quality standard , procedure and CP ,USP,EP.

Have basic knowledge of medicine production process. Have using capability of quality management tool.

· computer and foreign language level

Fluently use OFFICE software .

Well English reading, speaking and writing skill.

· capability requirement

Good job morality, honest, careful, responsible.

High quality sensitivity.

Good comprehensively analytical ,communication, association, response and innovation ability.

Good learning skill.

Good training and instructing skill.

General leading and organizing ability.

· (complex character):

non-routine factor

Some factor are in mobile situation, including production ,GMP compliance, and other unexpected incident, and the dealing way to them usually leads to the next right or wrong result.

Some factors ,including person ,equipment and material ,can The daily management needs follow up change of SOP

situation needed to comprehensively analyze

Through daily inspection to find , solve problem and make proper determination in special condition.

· complex character of communication

Communicate with management persons in all level and operators to solve quality findings and quality hidden trouble.

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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