Job Purpose 岗位目的:
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.
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.
To develop the new instrument, optimize the instrument, to achieve the OEE of instrument.
Conduct the instrument training for QC member, provide the technical support and guide, coach all correctly use the instruments.
Prepare, review and revise SOP for equipments to ensure they are compliance with GSK policy and other regulatory.
Ensure BCP are in place for critical equipments.
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.
Lead and/ or participate in investigations arising from laboratory equipment/ incidents and propose effective CAPA to minimize reoccurrence.
Support analytical technical improvement and method implementing related to equipments, support lab management improvement.
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.
Responsible for the PIP related work and manage the fixed asset in QC together with other department, so that it can meet company requirement.
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.
Other projects and tasks as assigned by the line manager.
Specialised Knowledge 专业知识:
• 文化程度(学历/专业) education background
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
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