19 of 19 GAMP Jobs

DevOps, validation) using Agile, Scrum, and Kanban frameworks. Maintain high standards of quality, predictability, and regulatory compliance (21 CFR Part 11, ISO 13485, ICH GCP, GDPR, SOC2, Annex 11, GAMP 5). Develop and maintain delivery roadmaps and release plans; monitor risks, dependencies, and progress to ensure targets are met. Apply computer systems validation (CSV/CSA) and pragmatic risk More ❯

self-motivated. Desirable Qualifications Experience in embedded software or automation systems. Understanding of industrial protocols (e.g., OPC UA). Exposure to traceability and validation in regulated domains (e.g., GxP, GAMP). Tools Primary: Azure DevOps Secondary: Polarion Business Analyst/Requirement Engineer - (Software Requirements & DevOps More ❯

decision-making abilities Ability to translate complex technical concepts into clear business value Experience with Agile methodologies and product management tools (e.g., Jira, Aha!, Confluence) Familiarity with ISA-95, GAMP 5, and other industry standards Experience working with cloud-based MES platforms and integration with ERP/LIMS systems Familiar to work in a multicultural environment, with teams geographically distributed More ❯

on client’s site, no remote working • Working on regulated environment (GxP based) Skills: • Applying OS image on Laptop/Computer • 21 CFR Part 11 • 21 CFR Part 820 • GAMP 5 • Manual Testing, Qualification process More ❯

on client’s site, no remote working • Working on regulated environment (GxP based) Skills: • Applying OS image on Laptop/Computer • 21 CFR Part 11 • 21 CFR Part 820 • GAMP 5 • Manual Testing, Qualification process More ❯

on client’s site, no remote working • Working on regulated environment (GxP based) Skills: • Applying OS image on Laptop/Computer • 21 CFR Part 11 • 21 CFR Part 820 • GAMP 5 • Manual Testing, Qualification process More ❯

on client’s site, no remote working • Working on regulated environment (GxP based) Skills: • Applying OS image on Laptop/Computer • 21 CFR Part 11 • 21 CFR Part 820 • GAMP 5 • Manual Testing, Qualification process More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

expansion project, in line with strategic new product introduction. You will also support other Smart factory digital transformation initiatives. Must have: Experience working in GxP environment Good understanding of GAMP 5 Experience in supporting & maintaining IT business systems such as MES, SAP ERP Good understanding of all components that form an IT business system (hardware, software, data, networks, security, etc. More ❯

practices across the site. Maintain Compliance and own Computerized System Validation (CSV) Overview: Ensure all automation systems are validated and maintained in accordance with internal policies and regulatory expectations (GAMP 5, 21 CFR Part 11, EU GMP Annex 11). Responsibilities Oversee CSV activities for new and existing systems. Ensure changes are managed under the site change control process. Partner … with good prioritization in a dynamic environment. Cross-functional communication and stakeholder management. Ability to balance technical depth with GMP and business priorities. Technical Knowledge Strong understanding of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles. Experience with automation systems such as PLCs, SCADA, DCS, HMIs, MES and historian systems. Familiarity with industrial communication protocols More ❯

in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Good automated manufacturing practice (GAMP). Very good communication skills and demonstratable experience of working as part of cross functional teams. Experienced in working with cross functional teams to identify and implement changes and improvements More ❯

the validation and lifecycle management of both custom-built and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring 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 … 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 … demonstrate: Bachelor's degree in a scientific, engineering, or IT-related field. Minimum of 3 years’ experience in CSV within the pharmaceutical or life sciences industry. Strong understanding of GAMP 5, data integrity requirements, and applicable regulatory frameworks. Demonstrated experience with both bespoke and COTS systems across a range of GxP areas (e.g., manufacturing, quality control, clinical operations). Excellent More ❯

the validation and lifecycle management of both custom-built and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring 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 … 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 … demonstrate: Bachelor's degree in a scientific, engineering, or IT-related field. Minimum of 3 years’ experience in CSV within the pharmaceutical or life sciences industry. Strong understanding of GAMP 5, data integrity requirements, and applicable regulatory frameworks. Demonstrated experience with both bespoke and COTS systems across a range of GxP areas (e.g., manufacturing, quality control, clinical operations). Excellent More ❯