QC Microbiology Analyst
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.
- Intermediate knowledge of GMP regulations and standards, production processes and related technical requirements.
- Intermediate knowledge of GMP, GLP and pharmacopeia, safety regulations and data integrity.
- Understand the operation technique of testing and equipment/classified area.
- Good coordination and organizational skills.
- Good team work skills.
- Average interpersonal skills with good written oral communication skills and logical thinking ability.
- Proficient in using Office software.
- Has strong quality mind-set, analytical skills.
Support to reliable commercial supply & Compliance
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.
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.
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.
4.Complete the activities related to classified area, including clean and disinfectant, environmental monitoring, etc., to ensure no impact on the testing.
5.Review the records issued other analyst to ensure testing has been performed per applicable requirements, and results have been properly reported.
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.
7.Execute the analytical method validation.
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.
9.Perform the oversight on the environmental monitoring. Perform trend analysis and report timely according to the site SOP.
10.Train new analysts according to the site SOP.
11.Support and co-ordinate the validation, calibration and maintenance of equipment in QC lab.
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.
13.Perform other jobs assigned by QC Section leader.
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.
1.Follow Tianyuan EHS policy and ensure safety and health during the work, including use of protection equipment as appropriate.
2.Responsible for reduction of lab waste and EHS risk, avoiding working injury.
3.Responsible for proper usage and effective management of bio-hazard substances to ensure biosafety in QC lab.
You may apply for this position online by selecting the Apply now button.
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