南京招聘

Job Purpose and Key Responsibilities 岗位的目的和主要岗位职责:

Job Purpose 岗位目的:

监督生产过程的GMP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；参与内部审计及供户审计；起草修订相关SOP。

Supervise production GMP 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 and supplier audit; draft relative SOPs, perform the training to Value stream.

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. 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.

3. 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。

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.

4. 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.

5. 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.

6. 参与相关验证活动。

Involve in the relative validation activity.

7. 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.

8. 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.

9. 通过衡量、跟踪KPI持续改进成品释放周期，BNRFT，偏差调查等。

Improve FG release cycle, BRNFT and deviation investigation, etc. by measuring and tracking KPI.

10. 不断提高发现问题和解决问题的能力。

Improve the ability of finding and solving problems.

11. 完成产品年度质量回顾报告

Complete PPR.

12. 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, EHSS etc. and company policy. Adherence to standard operating procedures.

Specialised 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.

· 任职经验working experiences

4年以上质量相关经验。

4 years or above, quality management experiences

· 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.

· 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.

较好的培训教导能力。

Good training and instructing skill.

一定的领导、组织能力。

General leading and organizing ability.