天津招聘

Key Responsibilities主要岗位职责:
1.督促所辖生产区域严格执行各种质量检验标准，严格遵守安全/劳保规则，对工作领域的GMP执行情况负责。
Make sure all kinds of production activity comply with the requirement of in-process-control standard; comply with security and working protection principle, be responsible for the site GMP compliance.
2.对生产区域提供GMP的指导。 作为质量指导和顾问对价值流进行支持，通过协同和主动的质量改进活动，审计，关注预防措施以支持公司商业目标的达成。
Provide GMP advice to production area. Act as quality coach and mentor to value streams through alignment, proactive involvement in quality improvement and inspection readiness activities and focusing on preventive activities in support of achieving business objectives.
3.指导激励团队。
Coach and motivate team、
4.追踪偏差处理，调查问题根源，提出和落实纠正预防措施，向OQ经理汇报并提供建议。
Deal with deviations, find out root cause, point out and trace corrective action and preventive action, report detailed information and recommendations to OQ manager.
5.对所有工厂内的相关区域包括包装/制造/备料/储存/工程/QC区域进行GMP巡检，保证时时了解工厂内 GMP执行水平，对违反GMP及SOP的行为进行制止，提出纠正措施并向上级主管报告。
Conduct periodic GMP inspection for each applicable area, such as package, production, dispensation and storage area; correct behavior which does not meet GMP and SOP requirement, train the operator and report the corrective action to supervisor.
6.周期性执行所辖生产区域的质量内审，保证符合相关现行法规和公司质量政策要求。
Perform internal audit periodically for relative production area and make sure production situation comply with executing relative Regulation and QMS.
7.产品放行前批档案审核，保证产品放行符合规范要求且无失误。
Review batch record before release, to ensure product releasing meet the SOP requirement
Specialised Knowledge 专业知识:
文化程度(学历/专业) Degree
(GMP) 大学本科药学或相关专业毕业；（或中级专业技术职称或执业药师资格）
Bachelor, Pharmacy or related. (or have Pharmaceutical Engineering certification or certified pharmacy)

任职经验Experiences
(GMP)具有至少五年从事药品生产和质量管理的实践经验，从事过药品生产过程控制和质量检验工作。或经
过工厂评估具备相应知识和资质的培训.
More than 5 years experiences of production and quality management. Have experience of quality control and quality
assurance. Or equipped with equivalent knowledge and kill assessed by site. (e.g. sufficient training)

专业知识/技能speciality knowledge/skill
了解GSK质量组织和QMS系统。
Know GSK quality organization and QMS system.
熟悉相关GSK报告系统/衡量系统/CAP系统，了解质量审计系统。
Be familiar with GSK report system /evaluation system/CAP system/audit system.
了解相关国家和地方质量政策法规(GMP，GLP等)。
Know relative state and regional law, such as GMP, GLP.
熟悉公司所有相关质量标准/规程，及现行CP和国际通用标准如USP，EP。
Be familiar with all company quality standard, procedure and CP, USP, EP.
具有一定的药品生产工艺，验证知识和经验以及质量管理工具应用能力。
Have basic knowledge of medicine production process, validation. Have using capability of quality management tool.
具有质检或相关证书。
Have quality control or relative certificate.

葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地，该项目注册资金为1亿3千5百万美元，是葛兰素史克集团目前在华投资最大的项目，同时也是目前国内最大规模的外商投资制药企业。