The QA Validation Manager will primarily support Computerized System Validation (CSV) activities of in-house and vendor hosted (SaaS) systems, administer IT Change Control process.
- Administer IT Change Control and process IT Change Requests (ITCRs) to ensure changes are sufficiently assessed, validated and implemented on-time.
- Work with IT, Company stakeholders and software vendors to provide SDLC support.
- Provide QA validation oversight for new standalone and enterprise computerized system implementations, including vendor hosted systems.
- Author validation lifecycle documentation including VP, URS, FRS, DS, TM, VSR, protocols (e.g. IQ, OQ, PQ), and test scripts (e.g. UAT, Regression Testing) and support execution of validation testing.
- Ensures compliance with applicable regulations, standards and guidance (US FDA/MHRA/EU/ICH) and Company requirements.
- System releas