QC 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:2017-03-29
- 工作地点:天津-滨海新区
- 招聘人数:1人
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
职位描述:
Job Purpose 岗位目的:
To ensure the chemical testing of raw material, intermediate and finished product are completed in accordance with the regulatory and GSK quality standard. To continuously improve QC lab operations.
Key Responsibilities主要岗位职责:
? Support to commercial supply & Compliance
1. Complete chemical testing of raw materials, intermediates, finished products and other samples within the cycle time.
2. Management of reagents and reference standards used in QC lab to assure no shorten of them, e.g. co-ordinate the purchasing, periodic checking, and applying reagents from warehouse.
3. Maintain the stability chart and send the stability plan to QC analyst periodically. Put stability sample into chamber and pull out on time according to approved stability protocol.
4. Prepare the stability study protocol and implement stability testing of products including new product, annual review product and other samples need stability evaluation. Make trend analysis and summary report.
5. Prepare analytical method and instruments validation protocol, implement the validation plan and write summary report according to GSKT SOP.
6. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results are accurate and reliable.
7. Receive samples to be tested taken by VS operator and handle the test samples according to the relevant regulation.
8. Review CoA or records issued by other analyst.
9. Perform gap analysis on relative GQMP/GQP, pharmacopeia, CAP and other authorized reference document and then carry out action coming from gap analysis.
10. Draft, periodic review, and maintain relative product specification
11. Report any atypical or out of specification test result, investigate and find out root cause.
12. Prepare new product registration relevant document and draft specification and test method.
13. Implement or support the validation, calibration and maintenance of equipment in QC lab.
14. Draft SOP of equipment operation and activities in QC lab.
15. Initiate or cooperate GPS actively.
16. Perform other jobs assigned by QC Section Manager.
17. To take the responsibility for relative JD of micro analyst once to be rotated to micro lab.
18. Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures
? 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.
? GPS
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 GPS spirit.
Specialized Knowledge 专业知识:
? breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度(跨学科),所需知识的深度 (特定学科)
1. University graduate or higher in appropriate chemistry or related area.
2. Minimum 2 years experience in Pharmaceutical, food or biological company. Fresh graduate with outstanding academic results can be considered.
3. Familiar with good laboratory practice.
4. Above average interpersonal co-operator and communication skills.
5. Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP.
6. Master chemical professional skill.
7. Master analytical equipment operational and general maintenance skill.
8. Good English reading and writing skills.
9. Proven good computer skills.
10. Preferable understanding of organization structure, business operation and company culture of GSK.
11. Meticulous and careful in work.
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Job Purpose 岗位目的:
To ensure the chemical testing of raw material, intermediate and finished product are completed in accordance with the regulatory and GSK quality standard. To continuously improve QC lab operations.
Key Responsibilities主要岗位职责:
? Support to commercial supply & Compliance
1. Complete chemical testing of raw materials, intermediates, finished products and other samples within the cycle time.
2. Management of reagents and reference standards used in QC lab to assure no shorten of them, e.g. co-ordinate the purchasing, periodic checking, and applying reagents from warehouse.
3. Maintain the stability chart and send the stability plan to QC analyst periodically. Put stability sample into chamber and pull out on time according to approved stability protocol.
4. Prepare the stability study protocol and implement stability testing of products including new product, annual review product and other samples need stability evaluation. Make trend analysis and summary report.
5. Prepare analytical method and instruments validation protocol, implement the validation plan and write summary report according to GSKT SOP.
6. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results are accurate and reliable.
7. Receive samples to be tested taken by VS operator and handle the test samples according to the relevant regulation.
8. Review CoA or records issued by other analyst.
9. Perform gap analysis on relative GQMP/GQP, pharmacopeia, CAP and other authorized reference document and then carry out action coming from gap analysis.
10. Draft, periodic review, and maintain relative product specification
11. Report any atypical or out of specification test result, investigate and find out root cause.
12. Prepare new product registration relevant document and draft specification and test method.
13. Implement or support the validation, calibration and maintenance of equipment in QC lab.
14. Draft SOP of equipment operation and activities in QC lab.
15. Initiate or cooperate GPS actively.
16. Perform other jobs assigned by QC Section Manager.
17. To take the responsibility for relative JD of micro analyst once to be rotated to micro lab.
18. Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures
? 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.
? GPS
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 GPS spirit.
Specialized Knowledge 专业知识:
? breadth & depth across disciplines or functions; expertise in field required
所需知识的宽度(跨学科),所需知识的深度 (特定学科)
1. University graduate or higher in appropriate chemistry or related area.
2. Minimum 2 years experience in Pharmaceutical, food or biological company. Fresh graduate with outstanding academic results can be considered.
3. Familiar with good laboratory practice.
4. Above average interpersonal co-operator and communication skills.
5. Knowledge of GMP, GLP and pharmacopoeia e.g.USP, EP. CP.
6. Master chemical professional skill.
7. Master analytical equipment operational and general maintenance skill.
8. Good English reading and writing skills.
9. Proven good computer skills.
10. Preferable understanding of organization structure, business operation and company culture of GSK.
11. Meticulous and careful in work.
职能类别: 质量管理/测试工程师(QA/QC工程师)
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