compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As a CSV Specialist your responsibilities will include, although not limited to: Leading and executing validation activities for new and existing computerised systems, including both bespoke and COTS … solutions, in accordance with GAMP 5 principles. Performing risk assessments to define the appropriate validation strategy and documentation scope, aligned with the organisation’s overall GxP risk stratification framework. Preparing and maintaining validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), validation plans, protocols, reports, and traceability matrices. Working collaboratively with IT, QA, system owners, and vendors to ensure … compliant manner. Providing support during audits and regulatory inspections, addressing data integrity and CSV-related queries. Ensuring all system lifecycle documentation is maintained in accordance with internal SOPs and GxP standards. Assisting in developing implementing and testing disaster recovery plans for key computerised systems in collaboration with business departments. Contributing to the continuous improvement of CSV procedures, templates, and best More ❯
Oxfordshire, England, United Kingdom Hybrid / WFH Options
Hyper Recruitment Solutions
Develop, execute, and maintain test plans, test cases, and test scripts for Veeva applications and related systems. 2. Conduct system, integration, regression, and user acceptance testing in alignment with GxP and pharmaceutical industry standards. 3. Collaborate with business analysts, developers, and stakeholders to ensure requirements are fully understood and test coverage is comprehensive. 4. Ensure compliance with GxP, FDA, and … a pharmaceutical or life sciences environment. 3. A working knowledge and practical experience with Veeva applications (Vault, QMS, RIM, or similar). Key Words: Test Analyst/Veeva/GxP/pharmaceutical/life sciences/quality assurance/system testing/compliance/defect management/remote working/Oxford Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities More ❯
oxford district, south east england, united kingdom Hybrid / WFH Options
Hyper Recruitment Solutions
Develop, execute, and maintain test plans, test cases, and test scripts for Veeva applications and related systems. 2. Conduct system, integration, regression, and user acceptance testing in alignment with GxP and pharmaceutical industry standards. 3. Collaborate with business analysts, developers, and stakeholders to ensure requirements are fully understood and test coverage is comprehensive. 4. Ensure compliance with GxP, FDA, and … a pharmaceutical or life sciences environment. 3. A working knowledge and practical experience with Veeva applications (Vault, QMS, RIM, or similar). Key Words: Test Analyst/Veeva/GxP/pharmaceutical/life sciences/quality assurance/system testing/compliance/defect management/remote working/Oxford Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities More ❯
London, England, United Kingdom Hybrid / WFH Options
Focus on SAP
partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure and deploy Biovia OneLab workflows, protocols, and templates aligned with operational needs. Work with … successful solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide training and user … Biovia OneLab configuration and deployment Strong knowledge of system integration , including APIs, middleware, and data exchange protocols Deep understanding of Quality Management Systems (QMS) and laboratory workflows Familiarity with GxP compliance , validation documentation , and audit processes Excellent problem-solving, communication, and documentation skills If you are interested or would like to know more, please email jonathan.la@focusonsap.org with your CV More ❯
london, south east england, united kingdom Hybrid / WFH Options
Focus on SAP
partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure and deploy Biovia OneLab workflows, protocols, and templates aligned with operational needs. Work with … successful solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide training and user … Biovia OneLab configuration and deployment Strong knowledge of system integration , including APIs, middleware, and data exchange protocols Deep understanding of Quality Management Systems (QMS) and laboratory workflows Familiarity with GxP compliance , validation documentation , and audit processes Excellent problem-solving, communication, and documentation skills If you are interested or would like to know more, please email jonathan.la@focusonsap.org with your CV More ❯
slough, south east england, united kingdom Hybrid / WFH Options
Focus on SAP
partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure and deploy Biovia OneLab workflows, protocols, and templates aligned with operational needs. Work with … successful solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with GxP , 21 CFR Part 11 , and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness . Provide training and user … Biovia OneLab configuration and deployment Strong knowledge of system integration , including APIs, middleware, and data exchange protocols Deep understanding of Quality Management Systems (QMS) and laboratory workflows Familiarity with GxP compliance , validation documentation , and audit processes Excellent problem-solving, communication, and documentation skills If you are interested or would like to know more, please email jonathan.la@focusonsap.org with your CV More ❯
delivery and alignment with platform capabilities. Set up and manage integrations between OneLab and other enterprise systems (e.g., LIMS, ELN, ERP, MES). Ensure compliance with regulatory standards including GxP, 21 CFR Part 11, and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness. Provide training and support to … and data exchange protocols. Deep understanding of Quality Management Systems (QMS) and laboratory workflows. Ability to effectively communicate and collaborate with both business stakeholders and technical teams. Familiarity with GxP, validation documentation, and compliance standards. Excellent problem-solving, documentation, and interpersonal skills. More ❯