Chemical Lab Leader
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:1
- 工作经验:五年以上
- 学历要求:本科
- 职位月薪:面议
- 职位类别:质量管理/测试主管(QA/QC主管)
职位描述
Role Purpose:
? To provide leadership of GSKT OE project (scope: Chemical Laboratory) to improve flow through laboratory and improve capability of test methods and QC processes.
? Make sure the QC lab routine products test and release timely and meet the market demand.
Key Accountabilities/Responsibilities:
? GSKT Lab OE
1. Responsible for Lab OE projects, in charge of the overall lab continuous improvement.
2. Optimize laboratory layout and become more logical
3. Coach the OE projects related to Laboratory
4. Improve the working efficiency of Laboratory
5. Improve the process capability of laboratory in order to can support better to commercial supply
6. Reduction of test items and Reduction of testing cycle time
7. Establish standard work flow, Implement and improve the standard work in QC lab.
8. Laboratory visual management and consumable management.
9. Increase laboratory cost saving and lab energy saving.
10. Optimize other laboratory works using OE tools, i.e. Kanban, MSA
11. More implement of NIR equipment in routine tests in QC lab.
12. To enhance OE/continuous improvement culture in Laboratory
? Support to commercial supply
1. Make the QC routine chemical test plan, be responsible for quality control of intermediates and finished products and assure the reliability and accuracy of test results, issue CoA and release them on time.
2. Handle the test samples according to the relevant regulation
3. To ensure QC lab testing complies with registered requirements and approved analytical methods.
4. Search for and contact with certified laboratories for third party testing related to product or project.
5. Report any atypical or out of specification test result, investigate and find out root cause
6. Prepare new product registration relevant document and draft specification and test method
7. Review test records of other analysts
8. Maintain the stability & retain system including stability plan, stability & retain sample management
9. Coordinate the calibration of QC lab instruments
10. L1 audit and document control coordinator in QC lab and tracking QC lab CAPA
11. Deliver Zantac samples to QP lab
12. QC lab equipment and reagent/solvents management
13. When section manager is out of office, acts as deputy
14. Perform other jobs assigned by QC section manager
? Compliance
1. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results are accurate and reliable
2. Implement or support the validation, calibration and maintenance of equipment in QC lab
3. Train and qualify new analysts
4. Support internal audits, GQA audits and regulatory inspection
5. Ensure all the OOS/OOT issues and deviations to be properly documented and effectively investigated on schedule.
6. Review QMS and CAP to find gaps against GSKT procedures timely, set up plan to fill in the gaps and supervise.
? 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.
Qualifications/Requirements:
? University graduate or higher in Pharmaceutical or related area.
? Minimum 5 years experience in Pharmaceutical or biological company and minimum 3years QC control experience.
? Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP, JP.
? Master chemical professional skill. Good understand for new analytical technology.
? Master analytical equipment operational and general maintenance skill.
? Good English listening, reading and writing skills.
? Proven good computer skills.
? Leadership and Teamwork.
? Good interpersonal co-operator and communication skills.
? Preferable understanding of organization structure, business operation and company culture of GSK.
? Good initiative
? To provide leadership of GSKT OE project (scope: Chemical Laboratory) to improve flow through laboratory and improve capability of test methods and QC processes.
? Make sure the QC lab routine products test and release timely and meet the market demand.
Key Accountabilities/Responsibilities:
? GSKT Lab OE
1. Responsible for Lab OE projects, in charge of the overall lab continuous improvement.
2. Optimize laboratory layout and become more logical
3. Coach the OE projects related to Laboratory
4. Improve the working efficiency of Laboratory
5. Improve the process capability of laboratory in order to can support better to commercial supply
6. Reduction of test items and Reduction of testing cycle time
7. Establish standard work flow, Implement and improve the standard work in QC lab.
8. Laboratory visual management and consumable management.
9. Increase laboratory cost saving and lab energy saving.
10. Optimize other laboratory works using OE tools, i.e. Kanban, MSA
11. More implement of NIR equipment in routine tests in QC lab.
12. To enhance OE/continuous improvement culture in Laboratory
? Support to commercial supply
1. Make the QC routine chemical test plan, be responsible for quality control of intermediates and finished products and assure the reliability and accuracy of test results, issue CoA and release them on time.
2. Handle the test samples according to the relevant regulation
3. To ensure QC lab testing complies with registered requirements and approved analytical methods.
4. Search for and contact with certified laboratories for third party testing related to product or project.
5. Report any atypical or out of specification test result, investigate and find out root cause
6. Prepare new product registration relevant document and draft specification and test method
7. Review test records of other analysts
8. Maintain the stability & retain system including stability plan, stability & retain sample management
9. Coordinate the calibration of QC lab instruments
10. L1 audit and document control coordinator in QC lab and tracking QC lab CAPA
11. Deliver Zantac samples to QP lab
12. QC lab equipment and reagent/solvents management
13. When section manager is out of office, acts as deputy
14. Perform other jobs assigned by QC section manager
? Compliance
1. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results are accurate and reliable
2. Implement or support the validation, calibration and maintenance of equipment in QC lab
3. Train and qualify new analysts
4. Support internal audits, GQA audits and regulatory inspection
5. Ensure all the OOS/OOT issues and deviations to be properly documented and effectively investigated on schedule.
6. Review QMS and CAP to find gaps against GSKT procedures timely, set up plan to fill in the gaps and supervise.
? 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.
Qualifications/Requirements:
? University graduate or higher in Pharmaceutical or related area.
? Minimum 5 years experience in Pharmaceutical or biological company and minimum 3years QC control experience.
? Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP, JP.
? Master chemical professional skill. Good understand for new analytical technology.
? Master analytical equipment operational and general maintenance skill.
? Good English listening, reading and writing skills.
? Proven good computer skills.
? Leadership and Teamwork.
? Good interpersonal co-operator and communication skills.
? Preferable understanding of organization structure, business operation and company culture of GSK.
? Good initiative
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