Title: Validation Analyst. Benchtop instrument Validation is a must.
- Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
- Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCRs etc.)
- Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
- Author validation life cycle documents for the client's review and approval
- Route drafted documents for review
- Route-reviewed documents for workflow approval
- Request approval workflows to Doc Control
- Execute approved protocols in the GxP facility
- Understand SDLC process and SDLC methodology such as agile etc.
- Work with a global team in delivering validation project deliverables
- Manage change controls necessary for the project life cycle through process compliance and interface with Quality Assurance change control area
- Author change control documents for client review and approval.