4 of 4 GxP Jobs in Berkshire

primary business owner for the platformPartner with Biometrics, Data Science, IT, Quality, and external vendors to ensure platform reliability, compliance, and business value.Ensure GxP compliance, validation, inspection readiness, and data integrity requirements.Translate clinical analysis and reporting requirements into scalable platform capabilities supporting regulatory submissions and evidence generation.Drive adoption of modern ...

CSL Vifor is seeking a Quality Systems professional to support GMP-compliant quality systems across validation, calibration and document management. You will contribute to internal audits and continuous improvement programs while ensuring alignment with FDA ...

appropriate, timely validation/revalidation is maintained Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects Supports GxP health authority inspections by serving as subject matter expert forcomputerized systems topics Provides guidance on quality and regulatory requirements to project teams, internal stakeholders … other teams on GxP compliance relating to computerized systems Collaborates to resolve technical issues, provide quality training and communicate best practices Qualifications: Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated ...

Data Flow Documents Data Integrity Risk Assessments UAT Scripts & Execution Documentation Release Notes Business Communications Participate in system validation, periodic reviews, CAPAs, deviations and GxP compliance activities Collaborate with global stakeholders to continuously improve safety processes and supporting technologies What We're Looking For 5+ years' experience supporting Pharmacovigilance/… Drug Safety systems Strong knowledge of pharmacovigilance processes and operations Experience working within GxP-regulated environments Experience supporting validated computer systems Excellent business analysis skills with the ability to translate operational requirements into system solutions Strong stakeholder management and communication skills Experience supporting system implementations, upgrades, releases and change management ...