GlaxoSmithKline OQ specialist in Tianjin, China
Why Consumer Healthcare?
Right now, we’re on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It’s about truly helping people manage their health proactively in different ways as consumer needs evolve.
With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
Job Purpose 岗位目的:
监督生产过程的 GMP 和医疗器械符合情况；处理各类质量事件及质量投诉；批记录审核及放行产品；参与内部审 计；起草修订相关 SOP。
Supervise production GMP and medical device compliance; deal with all kinds of quality incident and quality complaints; Review batch records and release products ; participate the Level 1 and Level 2 audit; draft relative SOPs, perform the training to Value stream.
Key Responsibilities 主要岗位职责:
• 监督 GMP、医疗器械法规、SOP 及安全环保政策的执行达到国家和 GSK 的标准。 Supervise implementation of GMP, Medical Device, SOP and safety policy; ensure it meet national and GSK standards.
• 确保所在部门风险管理体系的有效性,包括积极主动对风险进行识别、评估和制定缓解行动计划 Accountable for functional risk management, includes proactive risk identification, assessment and mitigation plan development.
• 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.
• 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.
• 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/鼻贴生产区域进行 GMP 巡检，保证时时了解工 厂内 GMP 和医疗器械法规的执行水平，对违反 GMP、医疗器械法规及 SOP 的行为进行制止，提出纠正措施并 向上级主管报告。 Make GMP inspection for relative area periodically, 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 upper supervisor.
• 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.
• 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.
• 致力于不断改进工艺流程，提高工艺能力，降低产品缺陷率和客户投诉。 Engage in improving process capability, reduce defective ratio and customer complaint.
• 起草各类产品中控标准，SOP，培训指导价值流质量专员，保持并提高公司产品质量水准。 Draft all kinds of IPC standards and SOP, perform the training to quality specialist in VS, keep and improve the product quality standard step by step.
• 通过衡量、跟踪 KPI 持续改进成品放行周期，BNRFT，偏差调查等。 Improve FG release cycle, BRNFT and deviation investigation, etc. by measuring and tracking KPI.
• 不断提高发现问题和解决问题的能力。 Improve the ability of finding and solving problems.
• 完成产品年度质量回顾报告 Complete PPR.
• 理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、葛兰素质量管理体系及环境健康安全等方面 的标准和公司方针，遵守公司标准操作规程。 Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHS etc. and company policy. Adherence to standard operating procedures.
• 其它由主管安排的项目和工作 Other projects and tasks as assigned by the line
Specialized Knowledge 专业知识:
• 文化程度(学历/专业)education degree and speciality
药学大本以上相关专业毕业。 Bachelor degree or above, major in pharmaceutics.
• 计算机及外语水平 computer and foreign language level
熟练使用公司应用办公软件。 Fluently use OFFICE software .
英语水平较好(会话、阅读相当于 4 级) 。 Well English reading and speaking skill which is equivalent to CET-4.
• 能力要求 capability requirement
良好的职业道德，诚信、正直、认真、细致、责任心。 Good job morality, honest, careful, responsible. 较高的质量敏感性。 High quality sensitivity.
较好的综合分析、沟通、协调、应变能力、创新能力。 Good comprehensively analytical ,communication, association, response and innovation ability.
较强的学习能力。 Good learning skill. 适应倒班工作。 Can work in three shifts
Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.
We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .