Micro analyst
葛兰素史克(天津)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-03-04
- 工作地点:天津
- 招聘人数:若干
- 工作经验:二年以上
- 学历要求:本科
- 职位月薪:面议
- 职位类别:化学分析测试员
职位描述
Key Accountabilities/Responsibilities 主要工作职责:
? Support to commercial supply & Compliance
1. Complete microbiological limit testing of raw materials, intermediates, finished products and other samples within the cycle time.
2. Complete sterility testing of sterile products.
3. Routine monitor the Eye mo manufacturing area including air born microorganism, swab test, finger dab and gowning monitoring.
4. Implement the environmental monitoring (viable) of the other production clean area according to the sop regularly.
5. Review and make trend analysis regularly for the environmental monitoring results (viable).
6. Monitor the purified water system and make trend analysis and reports.
7. Identify the isolated microorganism.
8. Perform the preservative efficacy testing of Eye drops and disinfectant validation.
9. Conduct the microbiological challenge testing for autoclave validation, irradiation validation, media fill and other activity.
10. Prepare microbiological testing method and instruments validation protocol, implement the validation plan and give summary report.
11. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results accurate and reliable.
12. Handle the test samples, media and contaminated things according to the relevant regulation.
13. Report any atypical or out of specification test result, lead the investigation and find out root cause.
14. Implement or support the validation, calibration and maintenance of equipment in microbiological lab.
15. Draft SOP of equipment operation and activity in microbiological lab.
16. Give professional training to new analysts or sterile area operators.
17. Initiate or cooperate lean lab project actively.
18. Equipment and consumables ordering from the NIPP system for QC lab.
19. Perform other jobs assigned by QC section manager and Lab Lead.
20. To take the responsibility for relative JD of chemical analyst once to be rotated to chemical or RM lab.
21. Train and coach new analysts.
22. Optimize document management and test flow by using OE tools.
23. Cooperate with staff of other department in harmony to finish work well.
? EHS
1. Follow GSKT EHS policy and ensure safety and health during the work.
2. Responsible for reduction of lab waste and EHS risk, avoiding working injury.
3. Responsible for proper usage and effective management of virulent substances.
? OE
1. Keep lab at high level in 5S, standard work, leading time, and touch the quality KPI together with QC Team
2. Raise some JDI and ERA in themselves working area or other with flexible and OE spirit.
Qualifications/Requirements: 申请资格 / 职位要求:
? University graduate or higher in appropriate chemistry, microbiology or related area. Fresh graduate with outstanding academic results can be considered.
? Minimum 2 years experience in Pharmaceutical, food or biological company.
? Familiar with good laboratory practice.
? Above average interpersonal co-operator and communication skills.
? Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP.
? Master chemistry and microbiology related knowledge.
? 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.
? Support to commercial supply & Compliance
1. Complete microbiological limit testing of raw materials, intermediates, finished products and other samples within the cycle time.
2. Complete sterility testing of sterile products.
3. Routine monitor the Eye mo manufacturing area including air born microorganism, swab test, finger dab and gowning monitoring.
4. Implement the environmental monitoring (viable) of the other production clean area according to the sop regularly.
5. Review and make trend analysis regularly for the environmental monitoring results (viable).
6. Monitor the purified water system and make trend analysis and reports.
7. Identify the isolated microorganism.
8. Perform the preservative efficacy testing of Eye drops and disinfectant validation.
9. Conduct the microbiological challenge testing for autoclave validation, irradiation validation, media fill and other activity.
10. Prepare microbiological testing method and instruments validation protocol, implement the validation plan and give summary report.
11. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results accurate and reliable.
12. Handle the test samples, media and contaminated things according to the relevant regulation.
13. Report any atypical or out of specification test result, lead the investigation and find out root cause.
14. Implement or support the validation, calibration and maintenance of equipment in microbiological lab.
15. Draft SOP of equipment operation and activity in microbiological lab.
16. Give professional training to new analysts or sterile area operators.
17. Initiate or cooperate lean lab project actively.
18. Equipment and consumables ordering from the NIPP system for QC lab.
19. Perform other jobs assigned by QC section manager and Lab Lead.
20. To take the responsibility for relative JD of chemical analyst once to be rotated to chemical or RM lab.
21. Train and coach new analysts.
22. Optimize document management and test flow by using OE tools.
23. Cooperate with staff of other department in harmony to finish work well.
? EHS
1. Follow GSKT EHS policy and ensure safety and health during the work.
2. Responsible for reduction of lab waste and EHS risk, avoiding working injury.
3. Responsible for proper usage and effective management of virulent substances.
? OE
1. Keep lab at high level in 5S, standard work, leading time, and touch the quality KPI together with QC Team
2. Raise some JDI and ERA in themselves working area or other with flexible and OE spirit.
Qualifications/Requirements: 申请资格 / 职位要求:
? University graduate or higher in appropriate chemistry, microbiology or related area. Fresh graduate with outstanding academic results can be considered.
? Minimum 2 years experience in Pharmaceutical, food or biological company.
? Familiar with good laboratory practice.
? Above average interpersonal co-operator and communication skills.
? Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP.
? Master chemistry and microbiology related knowledge.
? 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.
公司介绍
葛兰素史克公司在中国的历史最早可追溯至20世纪初叶。自20世纪80年代以来,在中国政府改革开放政策的感召下,公司在中国积极投资,将最先进的制药技术、最优质的产品、最新型的商业模式、***化的管理理念和市场营销技巧引入了中国。
葛兰素威康和史克必成公司于2000年12月完成全球性合并,2002年,葛兰素史克(中国)投资有限公司全面完成业务整合并正式宣布成立,成为中国目前规模***的跨国制药企业之一。公司业务由处方药、非处方药、疫苗和消费保健品4大部分组成,投资公司和地区总部位于北京,主要业务中心分设在上海、天津和香港。
葛兰素史克是最早在中国成功兴建合资企业的外国制药公司之一。在进入中国的20多年间,葛兰素史克先后成立了5家公司,目前2家为合资企业,总注册资本超过2.3亿美元。目前公司在全国28个主要城市(包括香港)设立了办事机构,在全国拥有近3000名员工,为中国的医药行业培养了一大批高素质的商业管理人员和技术骨干。
葛兰素威康和史克必成公司于2000年12月完成全球性合并,2002年,葛兰素史克(中国)投资有限公司全面完成业务整合并正式宣布成立,成为中国目前规模***的跨国制药企业之一。公司业务由处方药、非处方药、疫苗和消费保健品4大部分组成,投资公司和地区总部位于北京,主要业务中心分设在上海、天津和香港。
葛兰素史克是最早在中国成功兴建合资企业的外国制药公司之一。在进入中国的20多年间,葛兰素史克先后成立了5家公司,目前2家为合资企业,总注册资本超过2.3亿美元。目前公司在全国28个主要城市(包括香港)设立了办事机构,在全国拥有近3000名员工,为中国的医药行业培养了一大批高素质的商业管理人员和技术骨干。
联系方式
- 公司地址:天津经济技术开发区第五大街65号 (邮编:300457)
- 电话:13920189515