14 of 14 Permanent GxP Jobs in the South East

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 ...

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 ...

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 ...

Position Summary The Computer System Validation (CSV) Specialist is responsible for the governance, validation, and lifecycle management of all GxP-relevant computerised systems at site. This role ensures ongoing compliance with EU GMP Annex 11, MHRA Data Integrity Guidance, GAMP5 principles, and applicable global regulatory requirements. The position provides technical … inspection readiness and data integrity. Essential Functions Own and maintain the site Computerised Systems Validation (CSV) Master Plan. Manage the full validation lifecycle of GxP systems (URS, risk assessment, IQ/OQ/PQ, validation reports). Assess and approve system updates, configuration changes, and upgrades in line with change ...

regulatory requirements into practical, compliant solutions that support innovation Quality Management & Digital (QM&D) is responsible for the Innovative Medicine Quality Management System (IMQS), GxP ownership, and global Quality Management processes. Within QM&D, the Process & Data Management (PDM) team works with partners across Therapeutic Areas, Global Development, Global Regulatory … solutions that support business needs throughout the development lifecycle.In this role, you will contribute to improvement and compliance programs that require expertise across the GxP Quality Management System. Activities include Adopting Regulatory Requirements (ARR), Quality Framework integration, and strategic R&D Quality initiatives. The position evaluates, compares, maps, and integrates ...

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 ...

MedPharm Ltd in Guildford is seeking a CSV Specialist to govern and manage validated computerised systems (GxP) across the site, ensuring compliance with EU GMP Annex 11 and MHRA guidance. You will oversee the validation lifecycle (URS, IQ/OQ/PQ, reports), assess updates, perform risk assessments, and support ...

hour PAYE The Role We are looking for an experienced IT/OT Automation Engineer with a strong background in pharmaceutical manufacturing and GxP-regulated environments. You will support the delivery, upgrade and lifecycle management of validated automation and infrastructure systems, working at the interface between IT and Operational Technology … environments. Administer and support Windows Server 2022 or later environments. Support and integrate automated systems used within pharmaceutical manufacturing. Ensure systems comply with GxP requirements, including validation and documentation standards. Create and maintain GxP documentation, including IQ/OQ/PQ, SOPs, risk assessments and validation plans. Support the Software ...

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 ...

Milton Keynes. The role focuses on delivering, upgrading and lifecycle management of validated automation systems, interfacing IT and OT, with a strong emphasis on GxP compliance and documentation in a regulated pharma environment. 6-month contract, ASAP start, full-time. #J-18808-Ljbffr ...