QC Microbiology Analyst

Basic qualifications:

To ensure the microbiological testing of utility monitoring, raw materials, intermediates and finished products made at Tianyuan or imported vaccines are completed in accordance with the registered specifications, Chinese Pharmacopeia and with cGMPs, and GSK quality standards, and that test results are reported accurately and timely.

负责微生物学检验包括天元共用系统监测、原辅材料、中间品、本地化产品以及进口产品的检测,确保符合注册标准、中国药典、现行版GMP和GSK质量标准的要求,及时准确地完成检测及报告。

Preferred qualifications:

至少3年在药品、食品或生物公司从事生物学相关工作经历或同等学习工作经历。有生物制药企业或无菌生产企业经验者优先。

  • Intermediate knowledge of GMP regulations and standards, production processes and related technical requirements.

具备一定的产品标准、生产过程及其各项指标和技术要求知识。

  • Intermediate knowledge of GMP, GLP and pharmacopeia, safety regulations and data integrity.

具备一定的GMP、GLP、药典、安全法规和数据完整性知识。

  • Understand the operation technique of testing and equipment/classified area.

理解实验室检测、设备、洁净室的操作技巧。

  • Good coordination and organizational skills.

有良好的协调和组织能力。

  • Good team work skills.

良好的团队合作能力。

  • Average interpersonal skills with good written oral communication skills and logical thinking ability.

基本的书面和口头沟通及逻辑思考能力。

  • Proficient in using Office software.

熟练使用office 办公软件。

  • Has strong quality mind-set, analytical skills.

有较强的质量意识和分析判别能力。

Details:

Support to reliable commercial supply & Compliance

支持可靠的商业供应&合规

1.Complete microbiological testing of utility monitoring, raw materials, intermediates, finished products and others samples within the lead time in accordance with applicable procedures, specifications, regulatory requirements (e.g. current Ch.P, GMP) and GSK quality standards.

按照相应的规程、标准、法规要求(如现行版中国药典和GMP)和GSK质量标准要求在检验周期内完成微生物学检验包括共用系统监测、原辅材料、中间品和产品检测。

2.Ensure all the quality control procedures and specifications related to microbiology testing are established, periodically reviewed and maintained in compliance with regulatory requirements and GSK quality standards.

确保微生物学检验相关的质控程序和质量标准均按照法规要求和GSK质量标准要求进行建立、定期回顾和维护。

3.Management of reagents, consumables, strains and reference standards used in QC lab to ensure no shorten of them, e.g. co-ordinate the purchasing, periodic checking, and applying reagents from warehouse.

管理检测用试剂、耗材、菌种及标准品,确保无物料短缺问题发生,如协调采购、定期确认和及时领料等。

4.Complete the activities related to classified area, including clean and disinfectant, environmental monitoring, etc., to ensure no impact on the testing.

完成洁净室的相关活动,包括清洁消毒、环境监测等,确保不影响日常检验。

5.Review the records issued other analyst to ensure testing has been performed per applicable requirements, and results have been properly reported.

审核其他分析员的检验记录,确保检验过程符合相应的要求并被准确地报告。

6.Report any atypical or out of specification/trend/expectation test result and participate in the investigation. Timely and effective communicate and escalate of quality issues to the appropriate levels of management.

报告异常或超标/趋势/期望的检验结果,并参与调查。确保及时有效沟通质量问题并上报至合适的管理层。

7.Execute the analytical method validation.

实施分析方法验证。

8.Perform gap analysis on relative GQMP/GQP, pharmacopeia, quality alert, CAPA globalization, CAP and other authorized reference document and then carry out action coming from gap analysis.

进行相关GQMP/GQP、药典、质量警告、全球化CAPA、CAP及其他经认可的文件的差距分析,并完成后续的改进行动。

9.Perform the oversight on the environmental monitoring. Perform trend analysis and report timely according to the site SOP.

对环境监测取样进行监督。根据相应的规程及时进行趋势分析及报告

10.Train new analysts according to the site SOP.

按照相关规程要求培训新的分析员。

11.Support and co-ordinate the validation, calibration and maintenance of equipment in QC lab.

支持和协调实验室设备的验证、校验及维保工作。

12.Complete the activities lean lab including visual and 6S management actively to keeping lab at high level in 6S, standard work, lead time and touch the quality KPI together with QC team.

积极完成精益实验室活动,包括可视化管理和6S管理,以保持实验室处于高水平的6S、标准化工作、检测周期,并与QC团队一起确保质量KPI符合既定的目标。

13.Perform other jobs assigned by QC Section leader.

执行QC区域负责人分配的其他工作。

14.Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, etc. and company policy. Adherence to standard operating procedures.

理解并遵守相关的质量、EHS及其他相关的当地法规,GSK QMS的要求及公司政策。遵守SOP相求。

EHS

1.Follow Tianyuan EHS policy and ensure safety and health during the work, including use of protection equipment as appropriate.

遵循天元EHS政策,确保工作过程中的安全和健康,包括防护措施使用。

2.Responsible for reduction of lab waste and EHS risk, avoiding working injury.

负责实验室废弃物数量级EHS风险的降低,避免发生工伤。

3.Responsible for proper usage and effective management of bio-hazard substances to ensure biosafety in QC lab.

负责生物危害物质的合理使用及有效管理,确保实验室生物安全。

Contact information:

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

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