51 to 75 of 84 GxP Jobs in the UK

inclusive environment for all employees. Role Summary This is a hands‐on senior engineering role with ownership across the computerised-system lifecycle, from initial GxP impact and supplier assessments through validation, release, operation, periodic review and retirement. The successful candidate will partner with Quality, Manufacturing, Engineering, IT, and system owners …/Cloud based systems validation utilising modern CSA approach. (E) Understanding of validation/assurance of AI and ML enabled systems, preferably in a GxP environment. (P) Strong technical writing and communication skills. (E) Experience of having supported FDA, MHRA, EMA or any other regulatory Audit inspections. (E) Qualifications Minimum ...

regulatory strategy for digital solutions in scope, including software and device classification, the applicable frameworks (e.g. EU MDR, FDA SaMD and DHT guidance, GxP and data integrity expectations) and the evidentiary standard required for each intended use. Ensure development, validation and change-control activities are conducted, documented and archived … health technologies or medical devices Working knowledge of the regulatory framework governing digital health technologies and clinical outcome assessments – including software and device classification, GxP, data integrity and privacy requirements – and the ability to apply it to design decisions Track record of leading cross-functional teams and influencing senior stakeholders ...

Title: IT Automation Project Execution Specialist (Pharma/GxP Manufacturing) Start Date: asap Location: Milton Keynes Duration: 6 Months Contract Type: Full Time Remote Role: No, onsite 5 days a week in Milton Keynes £31-53 PAYE PH or umbrella equivalent Description: This is a position for IT/… critical automation and infrastructure projects within a regulated pharmaceutical manufacturing environment. The role focuses on implementing and upgrading validated systems, ensuring compliance with GxP standards, and supporting the full system lifecycle (SDLC). You will work at the interface between IT and Operational Technology (OT), supporting manufacturing systems that ...

record leading clinical technology migrations, integrations, or large-scale data transfer programmes Strong understanding of clinical trial systems, data governance, validation, regulatory compliance, and GxP requirements Experience working with platforms such as Veeva Vault, CTMS, eTMF, Siebel CTMS, or related clinical development systems Ability to engage and influence business, quality … confidential discussion on your career. Keywords: Clinical, Technology, Systems, CTMS, eTMF, Veeva, Siebel, Migration, Data, Transfer, Integration, Validation, Compliance, Pharmaceutical, Biotechnology, Trials, Governance, Quality, GxP, Operations, Vendor, CRO, Transformation, Analytics, Inspection, Audit, Development, Programme, Strategy, Lifecycle ...

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 ...

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 ...

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 ...

datasets. Quality & AI-Driven Compliance: Lead Test-Driven Development (TDD) and Behavior-Driven Development (BDD) initiatives. Use AI test generators to produce HIPAA/GxP-compliant synthetic clinical trial datasets for automated validation. Leverage AI tools to auto-draft validation artifacts, data lineage manifests, and audit documentation required under GxP … quality checks. Domain & Regulatory Awareness: Strong foundational understanding of clinical trial data workflows (e.g., EDC architectures), healthcare data models, and life science compliance standards (GxP, HIPAA, GDPR), with the ability to apply AI/ML tools for schema mapping and zero-loss data integrity verification . Base ...

cloud-based and regulated environments Driving audit readiness, compliance programs and evidence-based assurance across frameworks such as ISO 27001, GDPR, SOC 2 and GxP Providing leadership on risk management, governance and security strategy Partnering with customers, auditors and key stakeholders on security reviews, assurance activities and regulatory compliance Supporting … several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS environments Customer-facing security ...

Business, Technology and Operations stakeholders. Design clinical solutions across data, AI, GenAI and technology-enabled R&D transformation. Ensure solutions and recommendations align with GxP, GCP and regulatory requirements. Develop thought leadership and support RFPs and business development activities. Contribute to EMEA R&D knowledge sharing and internal initiatives. Champion … consulting. Strong understanding of the end-to-end clinical trial lifecycle and clinical development processes. Knowledge of GCP/ICH guidelines and GxP regulatory requirements. Experience with clinical R&D systems, including clinical data, trial management, regulatory and safety platforms. Ability to engage with senior stakeholders and translate complex clinical ...

performance, including obsolescence management and application of functional and safety standards Develop and maintain procedures for integration of IT and IACS systems in both GxP and non-GxP environments Support development of OT architecture, standards, and governance, and collaborate with global and local stakeholders Drive communication and change management within … Experience with industrial automation systems and OT architecture, including integration with IT systems Familiarity with regulated environments and standards such as GxP (including GMP and GAMP5) and IEC 61508/61511 Understanding of cyber security risk assessments, controls, and system documentation Experience in system lifecycle management, including validation, change control ...

main point of contact for the Head of Product Management, surfacing technical constraints, feasibility, and delivery risk that should inform prioritisation and roadmap decisions. GxP-aware delivery. Ensure requirements and backlog items affecting GxP-relevant systems are documented and validated in line with Qureight's ISMS and Management of Software … requirements into implementation but not core to the role. Experience working on products used in clinical trials, healthcare, or another regulated environment. Familiarity with GxP, ISO 27001, or computerised system validation (CSV) concepts. Even better if A software engineering or development background, or other hands-on technical experience. What ...

main point of contact for the Head of Product Management, surfacing technical constraints, feasibility, and delivery risk that should inform prioritisation and roadmap decisions. GxP-aware delivery. Ensure requirements and backlog items affecting GxP-relevant systems are documented and validated in line with Qureight's ISMS and Management of Software … requirements into implementation but not core to the role. Experience working on products used in clinical trials, healthcare, or another regulated environment. Familiarity with GxP, ISO 27001, or computerised system validation (CSV) concepts. Even better if A software engineering or development background, or other hands-on technical experience. What ...

Initial Therapeutics, Inc. is seeking a GxP IT Systems Engineer to support manufacturing operations at their Harwell site in the UK. This role involves ensuring compliance with GMP standards, providing IT support, and maintaining system integrity. The ideal candidate will have a Bachelor’s degree in a computer-related field ...

We'rebuilding a connected, end-to-end Enterprise AI engine - uniting data foundations, AI technology, process reinvention, and business-facing AI to accelerate results across the whole value chain. Success depends on being exceptional connectors ...

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 ...

systems and Microsoft 365 Build in performance, scalability, security and segregation of duties for high transaction volumes Ensure the platform meets GxP, audit trail and validation requirements for a regulated business Partner with senior stakeholders and identify opportunities across Business Central and the Power Platform What you will bring Deep … Business Central using Azure DevOps and Git Strong Power Platform knowledge (Power Apps, Power Automate, Dataverse) Experience leading and mentoring developers Regulated or GxP experience, ideally medical device or pharmaceutical distribution ...

will work closely with cross-functional global teams to provide GCP support for Veeva products in varying Services areas by promoting GCP compliance, authoring GxP documents and records, reviewing project implementation deliverables, incident management review, and performing occasional supplier assessments. What You'll Do Verify compliance to applicable policies, procedures … work instructions and regulations in GCP project implementations Perform GxP/Quality review of various records, including project implementation deliverables Document audit findings and supports remediation efforts to project audit observations Promote GCP compliance by authoring records (e.g., project audit reports) Perform process improvement activities and incident/CAPA investigations ...

Business, Technology and Operations stakeholders. Design clinical solutions across data, AI, GenAI and technology‐enabled R&D transformation. Ensure solutions and recommendations align with GxP, GCP and regulatory requirements. Develop thought leadership and support RFPs and business development activities. Contribute to EMEA R&D knowledge sharing and internal initiatives. Champion … consulting. Strong understanding of the end‐to‐end clinical trial lifecycle and clinical development processes. Knowledge of GCP/ICH guidelines and GxP regulatory requirements. Experience with clinical R&D systems, including clinical data, trial management, regulatory and safety platforms. Ability to engage with senior stakeholders and translate complex clinical ...

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 ...

Finance teams spend less time on manual processes and can focus on their core work. As several of these systems hold or track GxP-relevant records, i.e. trial imaging in Box and validated change history in JIRA, this is not "citizen developer" tinkering. Every automation that touches a regulated system … maintain integrations across Box, JIRA, HiBob and other platforms, including MCP-based and Claude Code-driven automations to remove manual handoffs between teams. GxP-aware delivery. Ensure every automation touching a validated or GxP-relevant system is version-controlled, peer-reviewed, documented, and validated in line with Qureight's ISMS ...

force multiplier, aligning stakeholders across technical and non-technical teams Bringing discipline to delivery across both fast-moving AI/ML development and regulated, GxP-adjacent processes What you'll bring: An original background as an engineer or scientist, with a career since built in programme or delivery management Proven … Technical Programme Manager | OKR | OKRs | Objectives and Key Results | Delivery Lead | Product Delivery | AI | Artificial Intelligence | Machine Learning | ML | Techbio | Life Sciences | Clinical Trials | GxP | Scale-up | Cross-functional Leadership | Stakeholder Management | PMO | Agile ...