Responsibilities:

• 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 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 GxP facility.
• Understand SDLC process and SDLC methodology such as agile etc.
• Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables.
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.
• Author change control documents for client review and approval.

Requirements:

• Prior experience with benchtop instrument experience is a must.
• Bachelor’s/ master’s degree or equivalent in a scientific or health care field.
• 7+ years’ experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred.

• 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 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 GxP facility.
• Understand SDLC process and SDLC methodology such as agile etc.
• Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables.
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area.
• Author change control documents for client review and approval