1 to 25 of 43 GxP Jobs in the UK excluding London

storage and endpoint management solutions Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical ...

equivalent project management certification preferred. Preferred Qualifications Experience supporting Global Patient Safety, Pharmacovigilance, Drug Safety, Clinical Development, Regulatory Affairs, Medical Affairs, or other GxP-regulated functions. Experience within Functional Service Provider (FSP) or Contract Research Organization (CRO) environments. Experience supporting global client partnerships and matrix organizations. Lean Six Sigma ...

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 ...

improvement across the department. About You A relevant Biochemistry, Biomedical, or other applicable science-based degree At least 4 years' laboratory experience in a GxP environment, including 2 years in a management capacity At least 4 years' experience working with HPLC, UPLC, and LC-MS/MS, with frequent ...

careers/orion-as-an-employer/. We are seeking an individual with experience in pharma or industrial environments, including an understanding of GxP compliance and IT support in regulated environments. Skills & Qualifications: Technical Proficiency: Windows, macOS, Microsoft 365, Active Directory, VPN, remote desktop tools, and enterprise applications. Customer ...

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 ...

equipment issues, supporting CAPA activities. Assist with installation, commissioning, qualification and validation activities, including IQ/OQ/PQ. Ensure compliance with GMP, GxP and ALCOA+ data integrity requirements. Analyse data from serialisation, automation and production systems to identify opportunities for performance improvement. Support and maintain PLCs, HMIs, scanners, printers ...

Engineering or a related field. Significant’ experience in a Systems Analysis, Business Analysis or related analytical role. Experience of software delivery activities within a GxP/pharmaceutical/other regulated environment. Demonstrable experience of leading, supervising or line-managing a team of analysts or related professionals. A record of being ...

mindset, make resource trade-offs, and drive measurable commercial outcomes. Navigate the tension between speed-to-market and regulatory compliance (GxP, 21 CFR Part 11, GDPR, HIPAA). Cultivate strategic partnerships with data providers and standards bodies (CDISC, HL7 FHIR) to accelerate Evinova's product capabilities. Champion a culture ...

testable requirements and operational evidence; contribute to threat modeling and risk assessment using leading frameworks; support risk-tiered controls across research, business, regulated and GxP-relevant use cases; document residual risk, control limitations, exceptions and approvals to enable defensible decisions; engage vendors and peers to evaluate capabilities and shape adoption ...

type of person who loves experimenting, learning new frameworks, or building side projects in your spare time. (Bonus: Experience or familiarity with GxP/GDPR or the Pharmaceutical industry is a nice-to-have, but certainly not a dealbreaker!) What we offer in return Flexible benefits package Opportunities for learning ...

strategies to ensure business continuity.•Utilise the service management tool (e.g. ServiceNow) to record, update, and manage incidents.Security, Compliance & OT Considerations•Implement and maintain GxP-compliant IT infrastructure within a regulated pharmaceutical environment.•Ensure CFR Part 11 and data integrity requirements are met across all IT/OT systems.•Implement ...

lifecycle — from early research through to commercial supply.We are seeking an experienced Pharma Quality SpecialistConsultant to join our Life Sciences consulting team, specialising in GxP Quality Management System (QMS) design, transformation and implementation.In this role, you will advise clients across pharmaceutical, biotechnology and related life sciences environments, supporting compliance with … client engagements, applying your quality expertise to deliver tangible impact. Your work will include:QMS design and process transformationLeading the design and implementation of GxP‐compliant QMS across R&D, manufacturing, clinical and distribution environments.Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned ...

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 ...

enhancements and new implementations. You will be responsible for generating validation documentation and ensuring systems are maintained in a validated state, compliant with GxP and data integrity requirements.Stakeholder Collaboration: Work closely with Manufacturing Operations, Quality Assurance, and Process Science teams to gather system requirements and provide updates on technical activities.User … Emerson Syncade, POMSnet).Manufacturing Environment Experience: Experience working directly in a manufacturing environment, preferably within the pharmaceutical, biologics, animal health, or another GxP-regulated industry.Regulatory Knowledge: A working knowledge of GxP (Good Manufacturing Practices) and familiarity with computer system validation (CSV) principles.Process Control Understanding: Familiarity with industrial automation concepts, including ...

improvement of the Company’s IT infrastructure. The IT Analyst role ensures the availability, reliability, security and compliance of IT systems supporting business and GxP activities. Working within a regulated environment, the position contributes to computer system validation, cybersecurity, data integrity, audit readiness and regulatory compliance. Your Responsibilities Infrastructure & Network … requests, problems and changes using ITIL principles. Maintain SLA performance and perform root cause analysis for recurring issues. Maintain IT asset and configuration records. GxP Compliance and Validation Responsibilities Support validated and regulated computer systems throughout their lifecycle. Participate in user requirements gathering, risk assessments, validation planning and test execution. ...

trails, electronic signatures, role-based access, segregation of duties, data integrity, master data, time synchronisation and lifecycle controls . Ensure architectural decisions support GMP, GxP, data integrity, patient safety, product quality and inspection readiness . Partner with Engineering, Automation, Manufacturing, Quality, Validation, Cybersecurity, Infrastructure, Data, Applications and senior site stakeholders. … have: Strong experience designing OT/IT architectures within pharmaceutical, life sciences, chemical, food & beverage or similarly regulated manufacturing environments . Strong understanding of GxP/GMP regulated environments and the implications these have on technology architecture. Experience with IT/OT convergence and industrial control environments . Strong understanding ...

will bring a strong background in IT infrastructure, Windows Server, AD/GP, and virtualization (VMware/Hyper-V), with experience in regulated environments (GxP) being a plus. Expect 36-hour weeks and an on-site presence in Haverhill. #J-18808-Ljbffr ...

with architectural best practices. Key Responsibilities: Build and optimise scalable data pipelines using Databricks and Apache Spark (PySpark). Ensure performance, scalability, and compliance (GxP and other standards). Collaborate on requirements, design, and backlog refinement. Promote engineering best practices including CI/CD, code reviews, and testing. Research ...

another regulated environment. Familiarity with document management or OCR tools. Experience using Jira and Confluence. Awareness of clinical governance or quality frameworks (for example GxP, ISO 13485, DCB0129/0160). What success looks like in the first 6 months Full ownership of e-sign configuration and first-line troubleshooting ...

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 ...

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 ...