Search Results: 2 vacancies
...&Q activities as required.
- Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)
- Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.
- Management of any aspect of C & Q, verification...
..., particularly 21 CFR Parts 11 & 820ion
•Experience with reviewing computer validation documentation (Validation Plans, IQ, OQ, PQ, RTM, Reporting)
•Familiarity with GAMP5 Guideline for “Risk Based approach to GxP Compliant Computerised systems
•Understanding of CSA...