System Manager Clearance & Lit Intelligence > Joboolo BE :
Société : Next-Link Lieu : Zaventem Flanders Site source : Talent BE
Proactively identify any needs for updates as well as informing the Source clear community and posting Newsflash and Tip’s on the Clearance collaboration site o Participate in content roadmap activities for technologies improvement - Source Clear Change Request Manager, which includes the following activities:
o Manage Source Clear Change Requests (CRQ) - release activities (4 to 5 per year):
§ Investigate Collect and keep up to date CRQ list and investigations § Build CRQ release planning & tasks (release cycle of 8 weeks) in accordance with GxP validated procedure § Update documentation in source Controlled docs (URS, TMX…) § Manage business PQs (Protocol Qualifications) in QALM system § Organize system testing as per validation requirements § Release communication to users o Veeva release activities § Analyze the auto-on enhancements versus configurable changes and their impacts § Update controlled documentation:
Functional Risk Assessment (FRA) § Elaborate, validate with core team and finally release communication to users - Be fully familiar with process, practical guidance and system training for clearance of product/disease promotional/educational/press material and comply with GCC SOP 008512 and validation requirements - Support GCC with audits and inspections as required Requirements • Experience with Veeva Vault PromoMats – configurations, updates, system enhancements • Knowledge of GxP • Project management experience Next-Link ZaventemFlanders