10 of 10 GxP Jobs in the South East

Data to account for E2E views - bringing clarity via comprehensive persona-based analytics and insights to drive decisions and ensure various compliance and GxP requirements Orchestrates impact assessments that explicitly include retrofit, current and future assessments of ways of working, SOPs, training, communications and downstream provisioning impacts; manage upstream/ ...

pharmaceutical discipline. Minimum of 5 years’ regulatory experience, ideally within radiopharmacy, sterile manufacturing or aseptic processing. Proven experience with GMP, MHRA expectations and broader GxP requirements. Experience supporting commercial and IMP product development, including clinical trial supply. Strong understanding of regulatory inspections and authority interactions. Experience working across multi‐site ...

with infrastructure considerations (networking, hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model ...

drive continuous improvement across validation, calibration, and document management. You will write and manage validation plans, participate in audits, and advise project teams on GxP requirements for computerized systems, with collaboration across functions. The role requires a bachelor in engineering or a relevant science and at least 5 years ...

role will be hands on, so the candidate willneed to be comfortable carrying out installations and configurations onProduction servers and workstations in a non-GxP environment. Key Responsibilities TechnicalDeployment: Overseeing all project phases, from initiation to go-livescientific systems within Patient Solutions scope. HandsOn Technical: Perform application installations and configurations ...

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and ...

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 ...

Join us as a Senior IT Quality & CSV Specialist. As Senior IT Quality & CSV Specialist you will provide independent quality and validation oversight for GxP computerised systems and complex global IT projects within a pharmaceutical environment. You will work with project teams, system owners, IT teams and regulated business functions … ensure computer system validation activities are risk-based, compliant with global regulatory requirements, and inspection-ready. What you'll do: Provide quality oversight of GxP computerised systems throughout the full validation lifecycle. Review validation documentation including Validation Plans, Validation Reports, requirements, traceability matrices, design documentation, test plans, test reports, testing ...

experience working across Quality, Regulatory, Finance, and operational business teams Understanding of IT governance, change control, documentation, validation-aligned processes, and compliance expectations across GxP and non-GxP systems Kyowa Kirin International is an equal opportunities employer. No agencies please. #J-18808-Ljbffr ...

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 ...