Analyst

Site Name: China - Tianjin - TEDA - No.65 Fifth Avenue Posted Date: Feb 8 2023 Job Purpose 岗位目的: 1. To ensure the testing of raw material, intermediate and finished product are completed in accordance with the regulatory and GSK quality standard. 2. Ensure all systems and process are validated and maintained in a complied manner according to GMP, GSK QMS and regulations. Key Responsibilities主要岗位职责: Test raw material, intermediate and finished product with registered requirements, pharmacopeia and approved analytical methods, ensure the test results are accurate and reliable and complete within cycle time. Ensure the operation comply with procedure, basic GMP and other equivalent standards, built appropriate local procedure to meet QMS and local regulation requirement, ensure high standard product quality and compliance with GMP and equivalent standards. Ensure compliance with Date Integrity ALCOA+ principle. Ensure compliance to local industry and government regulations, GSK standards, procedures, guidelines and implementation of GSK EHS Management System at the site and ensure continuous EHS improvement in all work processes. Ensure that contribute to site maintains the best EHS performance and report to managers gaps and areas of improvements. Perform sample management in lab. Perform reagents and reference standards management, to assure no shorten of them and meet relative requirements. Perform stability management. Participate in analytical method and instruments validation in a manner that is compliant with GMP, GSK QMS, local regulations and Site Validation Master Plan. Monitor key systems and make trend analysis and reports according to relative procedure. Perform gap analysis on relative QMS documents, pharmacopeia, ATS and other authorized reference document Draft PPR and maintain relative product specification. Report any atypical or out of specification test result and support investigation. Prepare new product registration relevant document and draft specification and test method. Support the validation, calibration and maintenance of equipment in QC lab. Maintain documents including SOP/WI/Forms/Logbooks related to QC department, make sure local SOP requirements comply with GMP, GSK QMS and local regulations. Ensure actual practices comply with SOP requirement and optimize procedure during routine work. Perform MM audit and complete CAPA in agreed timeline. Review records/documents to ensure right first time and make sure all records/documents are prepared in accordance with GMP record. Participate in lean lab project actively. Train new analysts. Perform other jobs assigned by QC Section Manager and Head of Quality. Why you? Basic Qualifications: University graduate or higher in appropriate chemistry or related area. Minimum 2 years experience in Pharmaceutical, food or biological company. Fresh graduate with outstanding academic results can be considered. Familiar with good laboratory practice. Above average interpersonal co-operator and communication skills. Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. ChP. Master chemical professional skill. Master analytical equipment operational and general maintenance skill. Good English reading and writing skills. Proven good computer skills. Preferable understanding of organization structure, business operation and company culture of GSK. Meticulous and careful in work. *LI-GSK GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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