Chemical Analyst
葛兰素史克全球生产及供应(中国)
- 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
- 职位月薪:面议
- 职位类别:化学分析测试员
职位描述
Key Responsibilities:
?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-ordate 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.Train new analysts.
16.Initiate or cooperate lean lab project actively.
17.Perform other jobs assigned by QC section manager.
18.To take the responsibility for relative JD of micro analyst once to be rotated to micro lab.
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.
Specialized Knowledge :
?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. CP.
?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.
?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-ordate 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.Train new analysts.
16.Initiate or cooperate lean lab project actively.
17.Perform other jobs assigned by QC section manager.
18.To take the responsibility for relative JD of micro analyst once to be rotated to micro lab.
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.
Specialized Knowledge :
?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. CP.
?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.
公司介绍
葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地,该项目注册资金为1亿3千5百万美元,是葛兰素史克集团目前在华投资最大的项目,同时也是目前国内最大规模的外商投资制药企业。
联系方式
- 公司网站:http://www.gsk.com
- 公司地址:苏州工业园区苏虹西路40号
- 邮政编码:215021