SAP CSV计算机验证顾问

- QA or IT background in pharm industry
- SAP skill is a must
- At least 3 years computerized system validation experience and familiar with main stream regulatory policies. E.g. GAMP5, 21CFRPart 11, CFDA GMP Appendix 11etc.in terms of access control, audit trail, E-Signature, etc.
- Experience of validation activities to mid-large computerized system in Pharm industry, e.g. ERP, MES, LIMS, etc., also the IT infrastructure qualification activity
- Familiar with GMP Policy, standard, Pharm Quality Assurance process (Change, CAPA, Deviation, etc.)
- Excellent communication skills
- English skills is a plus

-Be familiar with change management, risk management and quality management.