Validation Expert GxP (m/f)

- Understand Application from project team and Support Business Teams
- Understand Validation process and documentation
- Understand expectations of your role in the project from project team
- Understand existing SOPs, SDLC
- Understand existing testing processes in application area
- Create/Review/Approve Validation documents from VCR through Certification Summary (including but not limited to: VCR, Project Plan, Val Plan, Protocols, Trace Matrix, ISSD, Cert Summary, Test Plan, Test Summary, IR, Release Notes)
- Attend VRB meetings and defend projects; provide opinions of best actions needed
- Create schedule of testing tasks within overall project schedule
- Lead and manage testing and validation activities in synchronization with project scope, schedule and objective
- Manage task allocation of team, review team's work and resolve issues
- Maintain contact with SQAE throughout project to ensure all deliverables are compliant and on-time
- Provide status, risks and mitigations to project team as per agreed reporting frequency
- Track and report project metrics to project team
- Participate in requirements walkthrough
- Create/Review protocols; pre-approve protocols
- Ensure pre approval of protocols by SQAE
- Post-approve protocols and ensure post-approved by SQAE
- Assist project team in coordinating with infrastructure teams for test environment
- Lead the IR process until all issues are resolved and documentation complete
- Excellent Computer System validation, global validation and Health Authorities guideline/regulation experience
- Excellent German language skills and very good English language skills (fluent)

Weitere Qualifikationen: IT consultant