QC Technical Supporting Lead實驗室技術支持
職位描述
Key Responsibilities主要崗位職責:
? Project
1. Qualification of Test method and equipment used in QC lab qualification to ensure they are validated and compliance with regulatory requirements. Prepare analytical method validation protocol, implement the validation plan and write summary report
2. All CAPEX could be well control and tracked to assure the equipment capability is suitable for working load and they are available on schedule.
3. Product project: to ensure all the actions relative to product project (Technical) are well planed and completed on schedule;
4. Communicate with other sites, i.e. Aranda, Jurong, Bad Oldesloe, Poznan and Boronia
5. Maintenance the API 100 information relative to QC.
6. Improve the knowledge of CDS system of QC staff
? Daily responsibility
7. Obey vocational moral and GMP/GLP disciplines strictly, ensure the test results are accurate and reliable
8. Report any atypical or out of specification test result, investigate and find out root cause
9. Prepare new product registration relevant document and draft specification and test method
10. Implement or support the validation, calibration and maintenance of equipment in QC lab
11. Train new analysts
12. Support internal audits, GQA audits and regulatory inspection
13. When section manager is out of office, acts as deputy
14. Perform other jobs assigned by QC section manager
15. 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
16. Stability trending module SME
? EHS
17. Follow GSKT EHS policy and ensure safety and health during the work.
18. Responsible for reduction of lab waste and EHS risk, avoiding working injury.
19. Responsible for proper usage and effective management of virulent substances.
Qualifications:
? University graduate or higher in Pharmaceutical or related area.
? Minimum 3 years experience in Pharmaceutical or biological company.
? 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 listening, reading and writing skills.
? Proven good computer skills.
? Good interpersonal co-operator and communication skills.
? Preferable understanding of organization structure, business operation and company culture of GSK.
? Good initiative
? Leadership potential
Besides the above technical knowledge of laboratory analysis and operations, this position also requires the individual to have a good command of GPS principles and knowledge. This role requires strong leadership capabilities to interact with GPS experts in the GMS network, section supervisors and lab analysts.
企業(yè)簡介
葛蘭素史克公司在中國的歷史最早可追溯至20世紀初葉。自20世紀80年代以來,在中國政府改革開放政策的感召下,公司在中國積極投資,將最先進的制藥技術、最優(yōu)質(zhì)的產(chǎn)品、最新型的商業(yè)模式、最現(xiàn)代化的管理理念和市場營銷技巧引入了中國。
葛蘭素威康和史克必成公司于2000年12月完成全球性合并,2002年,葛蘭素史克(中國)投資有限公司全面完成業(yè)務整合并正式宣布成立,成為中國目前規(guī)模最大的跨國制藥企業(yè)之一。公司業(yè)務由處方藥、非處方藥、疫苗和消費保健品4大部分組成,投資公司和地區(qū)總部位于北京,主要業(yè)務中心分設在上海、天津和香港。
葛蘭素史克是最早在中國成功興建合資企業(yè)的外國制藥公司之一。在進入中國的20多年間,葛蘭素史克先后成立了5家公司,目前2家為合資企業(yè),總注冊資本超過2.3億美元。目前公司在全國28個主要城市(包括香港)設立了辦事機構,在全國擁有近3000名員工,為中國的醫(yī)藥行業(yè)培養(yǎng)了一大批高素質(zhì)的商業(yè)管理人員和技術骨干。
職位發(fā)布企業(yè)
葛蘭素史克(天津)有限公司
企業(yè)性質(zhì):合資企業(yè)
企業(yè)規(guī)模:100-499人
成立年份:1995
企業(yè)網(wǎng)址:http://www.gsk.com
企業(yè)地址:天津經(jīng)濟技術開發(fā)區(qū)第五大街65號
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職位發(fā)布日期: 2017-12-04