Instrument Specialist

Your Responsibilities:
Job Purpose 岗位目的:
负责所有实验室所用的分析仪器验证、校正和维护,负责仪器相关SOP的制定,回顾和修订,以及有关的仪器操作保养的培训。负责相关CAP升版的回顾,并对相关SOP进行分析更新。对仪器相关的变更进行评估,配合仪器相关偏差的调查并提供切实可行的CAPA。负责实验室软件系统的维护和验证。负责仪器相关的分析方法的开发,验证和培训,支持分析技术及分析方法改进,协助实施实验室管理改进。负责实验室固定资产的管理。

Be responsible for the management activities of lab equipments, including validation, calibration and maintenance. Also in charge of SOP preparation, review and revision and conducting training for the lab analyst. In charge of CAP update tracking, analyzing gap and update the relevant SOP. Perform assessment on lab equipment and system change. Lead/ participate in investigations arising from equipment and propose CAPA. Maintain the software system of Lab, like CDS, LABC21; Support analytical technical improvement and method implementing about equipments. Management of lab fixed assets.

Key Responsibilities主要岗位职责:

• 负责QC设备、仪器的校正、验证、维护等管理工作,包括年度校正,验证,维护计划制定与实施,定期报告及回顾评估;
Do the calibration, validation, maintenance and management of instruments, draft and perform the calibration, validation annually master plan. Do the review of above. To achieve the management of instrument.
• 负责新仪器的应用开发,对现有仪器的合理利用及OEE的提高提出解决建议;
To develop the new instrument, optimize the instrument, to achieve the OEE of instrument.
• 负责协调和安排QC人员相应仪器使用及保养技能的培训,提供技术指导和工作支持,有效指导各组负责人及仪器使用人员正确使用仪器;
Conduct the instrument training for QC member, provide the technical support and guide, coach all correctly use the instruments.
• 负责仪器相关SOP的制定,回顾和修订,确保其符合GSK及其他法规的规定;
Prepare, review and revise SOP for equipments to ensure they are compliance with GSK policy and other regulatory.
• 确保关键仪器具备切实可行的BCP;
Ensure BCP are in place for critical equipments.
• 对实验室仪器及系统变更进行准确且完全的影响评估,保证所有受影响的部分都被充分的评估并及时升版收到影响的文件;
Perform accurate and thorough impact assessment on laboratory equipment, system change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.
• 主导/参与由于实验室仪器原因造成的调查,并提供有效的CAPA以减少重复发生的可能;
Lead and/ or participate in investigations arising from laboratory equipment/ incidents and propose effective CAPA to minimize reoccurrence.
• 支持仪器相关分析技术及分析方法的改进,协助实施实验室管理改进;
Support analytical technical improvement and method implementing related to equipments, support lab management improvement.
• 负责协调和安排与仪器供应商签订维护及校正合同,确保验证,校正和维护工作的按时进行,并确保不会对生产和正常使用产生影响;
Contact with the supplier for the maintenance and calibration contract for the equipments, to ensure that the calibration and maintenance can be carried out on time and have no influence on the product testing.
• 负责PIP相关工作,与其他部门协调管理实验室的固定资产,保证符合公司要求;
Responsible for the PIP related work and manage the fixed asset in QC together with other department, so that it can meet company requirement.
• 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.
• 其它由直线经理安排的项目和工作。
Other projects and tasks as assigned by the line manager.

LI-GSK

Why You?

Basic qualifications:
Specialised Knowledge 专业知识:
• 文化程度(学历/专业) education background
本科以上,分析或相关专业毕业;
Bachelor degree, analytical or related subjects
• 任职经验job experience
Minimum 2 years job experience,
• 专业知识/技能professional knowledge
了解GSK质量组织和QMS系统Understand GSK Quality Organization and QMS system
熟悉仪器操作和校正维护的知识,熟练掌握常用设备的操作,校正及维护Familiar with the equipment operation, calibration and maintenance
了解国家和地方质量政策法规(GMP,GLP,药监,药检,医疗器械法规等)Familiar with government and local regulation(GMP,GLP, SFDA, medical device)
熟悉公司相关质量标准/规程,现行CP和国际通用标准如USP,EPFamiliar with specification, cCNP USP,EP
• 计算机及外语水平computer and language
良好的电脑及业务软件的使用能力Good computer software operation skills
英语水平较好 Good English oral and writing skills.
• 能力要求/basic requirement
较强的学习能力,分析和创新能力 Strongly learn, analysis and innovate ability
具有创新和独立的工作能力Innovating with good independent working ability
具有较强的动手能力 Strongly hand on ability
具有较强的沟通能力 Good at communication

LI-GSK

Preferred qualifications:
N/A

Why GSK?:
N/A

Contact information:
You may apply for this position online by selecting the Apply now button.
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