GxP Validation Manager

Job description

Location: Bloomington, IN: **This role will require full-time presence (5 days / week) at the client site in Bloomington, IN** ** This role is not eligible for relocation assistance** Zifo is looking for a GxP Validation –Manager to join our team in Bloomington, Indiana. Responsible for leading the GxP Validation, Data Integrity and Remediation efforts for Analytical Instruments and Computerized Systems in accordance with applicable policies procedures and regulatory requirements. Job Responsibilities: - Define validation Strategy for computerized systems and analytical instruments utilized in GxP QC and Manufacturing labs - Understand SDLC process and SDLC methodology such as agile etc. - Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems - Participate/conduct Risk Assessments - Develop and maintain policies and procedures - Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.) - Perform Data Integrity Assessments for analytical instruments and Computerized systems and conduct meetings wi...