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 ❯
Dublin, Dublin City, City of Dublin, Republic of Ireland
Cognizant
and testing regiments. Experience writing software applications and web services using PI-SDK and AF-SDK Experience installing and configuring web-based applications. Requirements: Familiarity with ISA 88 and GAMP Minumim over 5+ years relevant industry PI experience Pharma industry experience perferred but not essential PI System Training Bachelor's Degree in appropriate field of study or equivalent work experience More ❯
Liverpool, England, United Kingdom Hybrid / WFH Options
Capgemini Engineering
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 ❯
Nottingham, Nottinghamshire, East Midlands, United Kingdom
UPPERTON LIMITED
in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Goodautomatedmanufacturingpractice (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 ❯
