9 of 9 GAMP Jobs

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 ❯

assessments and impact analyses for software changes. Document verification and validation results and maintain traceability matrices. Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5). Support audits and inspections by providing validation documentation. Test Planning and Design Develop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications. 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 ❯

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 ❯

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 ❯

troubleshooting, and time management skills. Excellent communication and teamwork abilities. Desirable: Knowledge of unit testing, integration testing, and mocking frameworks. Experience working in regulated industries or validated environments (e.g., GAMP). Location: Ipswich (hybrid 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 ❯