Search Results: 4 vacancies
...Market Manager
Requisition ID: 7515
YOU
As our Go To Market Manager you will create, execute and measure our UK Route to Market (RTM) Strategy across a 3-year time horizon and create the blueprint and roadmap for our External Growth and Market Share for the UK...
...&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...
...DQ, walk-downs, FAT, Commissioning/SAT, IQ, OQ and PQ.
Generation, maintenance, and approval of a Requirements Traceability Matrix (RTM) for each validated system.
Leadership of risk assessment processes, such as System/Component Level Impact Assessment (CLIA/SLIA) and...
..., 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...