11 of 11 GAMP Jobs

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 ❯

field of software testing strategy and methodology across NHSBT. You will ensure that testing processes with Systems Development and Integration department adhere to recognised good practice standards (including GMP, GAMP and GDP) and provide assurance that the quality of testing is appropriate to meet the needs of NHSBT. This includes cascading information about procedures and challenging poor practice when observed. More ❯

Desirable Experience of working in a first, second and third line technical support role Experience working with NHS Wales clinical and administrative applications Working knowledge of GMP and GAMP Experience of taking lead role in system design projects Skills Essential Excellent presentation and report writing skills Excellent understanding of problem, change and release management Ability to learn new technologies and More ❯

changes. Main duties of the job Lead the development, implementation, and ongoing maintenance of the test automation framework for blood technology systems, ensuring adherence to industry standards like GMP, GAMP, and GDP. Write and maintain test scripts, including manual, automated, and performance tests, to ensure the quality and safety of software systems. Carry out automated testing, produce test results, and 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 ❯

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 ❯

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 ❯

including user/functional requirements, validation plans, protocols, reports, and traceability matrices. Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice (GAMP) and agreed standards. Acting as a key contact for audit and inspection activity, particularly around data integrity and system validation. Participating in disaster recovery testing for critical systems and assisting … pace with regulatory expectations. What You'll Bring A proven background in a similar role within IT, Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation More ❯

including user/functional requirements, validation plans, protocols, reports, and traceability matrices. Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice (GAMP) and agreed standards. Acting as a key contact for audit and inspection activity, particularly around data integrity and system validation. Participating in disaster recovery testing for critical systems and assisting … pace with regulatory expectations. What You'll Bring A proven background in a similar role within IT, Engineering, Life Sciences, or a related domain. Familiarity with regulatory frameworks including GAMP and other relevant standards. Experience working with both custom and off-the-shelf platforms in regulated (GxP) environments-such as in manufacturing, quality control, or clinical settings. Strong written documentation More ❯

Automation Engineer Boden Group are recruiting on behalf of a Worldwide leading Pharma Organisation, fora brand new state of the art manufacturing facility based in Cambridgeshire. The Automation Engineer will serve as a senior member of staff in the setup More ❯