職位描述
Key Responsibilities主要崗位職責(zé):
？ 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.
