1 to 25 of 98 GAMP Jobs

computer systems, and acts as an information resource for the delivery teams and wider business. Skills & Experience Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.) Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure qualification, including More ❯

computer systems, and acts as an information resource for the delivery teams and wider business. Skills & Experience Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.) Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure qualification, including More ❯

and electrical wiring diagrams, communication networks, control panels, HMI, MES, SCADA, PLC and Historians. Broad and in-depth knowledge with practical experience of computer and application validation (preferably using GAMP methodology ), cGMPs , and 21 CFR Part 11 in an FDA regulated environment. Proven experience in lead ing and manag ing teams effectively, with a strong track record of fostering a More ❯

Design/Build/Test/Production lifecycle processes. • Participate where required, in the authoring and execution, or review and approval of computer software validation testing in accordance with GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance. • Create and run reports, to support Veeva performance reporting. • Be involved with other computer software validation … Design/Build/Test/Production lifecycle processes. • Participate where required, in the authoring and execution, or review and approval of computer software validation testing in accordance with GAMP 5 guideline and current Good Manufacturing (cGMP) regulations to maintain validation state and compliance. • Create and run reports, to support Veeva performance reporting. • Be involved with other computer software validation More ❯

IT Quality Analyst for Commercial Applications - GAMP 5 - CONTRACT OPPORTUNITY Contract A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. We specialize in providing quality resources in Information Technology (IT), Clinical More ❯

Develop and maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the design More ❯

Develop and maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the design More ❯

Develop and maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the design More ❯

systems implementation : Experience building automated quality checks, validation frameworks, or similar systems. Nice-to-haves Knowledge of relevant standards and compliance frameworks (e.g. ISO 27001, SOC 2, ISO 9001, GAMP 5, FDA 21 CFR Part 11, ALCOA+, BS 10008). Experience with regulated environments (GMP, HIPAA, etc.). Understanding of hardware-software integration. Experience with containerisation and orchestration (Docker, Kubernetes More ❯

working with diverse engineering teams and third-party contractors Strong financial acumen: experience managing cash flow, life-cycle costs, and project finances Knowledge of 21 CFR Part 11 and GAMP is a plus Automation, robotics, or pharmaceutical industry experience is advantageous Ambitious, confident, and professional: strong planning, communication, and organisational skills Full, clean driver's licence (required for site visits More ❯

knowledge of cGMPs: 21 CFR Parts 11, 210, 211; EU Directives 75/319/EEC, 2003/94/EC; Annex 11, and related GMP guidelines. Proficiency with GAMP guidelines (particularly GAMP 5): risk-based validation approaches for GxP systems. Experience in software development, testing, and validation processes. Strong quality audit and software quality metrics expertise. Bachelor's degree More ❯

stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies Maintain and enhance compliance documentation (SOPs, policies, validation More ❯

protocols (IQ, OQ, PQ), summary reports, and traceability matrices. Create and maintain documentation in accordance with company standards, regulatory guidelines, and industry best practices. Such as FDA 21 and GAMP 5. Ensure that all documentation is clear, concise, accurate, and easily understood by the target audience. Develop, write and revise work instructions and SOPs. Collaboration and Support: Work closely with More ❯

protocols (IQ, OQ, PQ), summary reports, and traceability matrices. Create and maintain documentation in accordance with company standards, regulatory guidelines, and industry best practices. Such as FDA 21 and GAMP 5. Ensure that all documentation is clear, concise, accurate, and easily understood by the target audience. Develop, write and revise work instructions and SOPs. Collaboration and Support: Work closely with More ❯

cross-functional engagement CSV Analyst - Requirements : Minimum of 3 years' experience in SAP validation within regulated (GxP) environments Strong understanding of CSV frameworks and regulatory requirements (GxP, FDA, EMA, GAMP 5) Familiarity with pharmaceutical manufacturing processes and SAP QM (Quality Management) modules Demonstrated expertise in authoring and managing validation documentation across the system lifecycle Experience working in complex stakeholder environments More ❯

Automation Engineer R&D North London £70,000 + Benefits Trevett Services is currently working with a client direct who are seeking the appointment of Automation Engineers on their new research and development site based in the North London area. More ❯

processing outsourcing and related sectors - Demonstrated success in enhancing quality management and business controls - 6-8 years of experience in a regulated environment (Medical Devices, CSV/CSA/GAMP) - Experience in leading change and preparing teams for adaptation About You - High-caliber leader who motivates and inspires teams - Effective communicator with stakeholders at all levels - Capable of leading teams More ❯

integrate new equipment with legacy systems. Ensure accurate documentation of logic changes, wiring diagrams, and system backups Maintain compliance with industrial and cyber-security standards (e.g., IEC 62443, NIS2, GAMP). Support commissioning, FAT/SAT testing, and the deployment of automation projects. Provide training to operators, technicians, and junior engineers on system operation and troubleshooting. Contribute to technical documentation More ❯

integrate new equipment with legacy systems. Ensure accurate documentation of logic changes, wiring diagrams, and system backups Maintain compliance with industrial and cyber-security standards (e.g., IEC 62443, NIS2, GAMP). Support commissioning, FAT/SAT testing, and the deployment of automation projects. Provide training to operators, technicians, and junior engineers on system operation and troubleshooting. Contribute to technical documentation More ❯

GxP requirements. Requirements: 5+ years of experience working as a Business Systems Analyst. Experience working in a GxP environment, such as Pharmaceutical, Biotechnology, or Medical Devices. Good understanding of GAMP 5. Experience supporting and maintaining IT business systems such as MES, SAP ECC. #J-18808-Ljbffr More ❯

and controlled documents. Support the project team as they work towards execution and handover Requirements: 3+ years experience of life sciences experience Knowledge and illustrated experience of working with GAMP, 21 CFR Part11 etc. Excellent ability to work with others showcasing strong communication and organisational skills Prior experience of working in automation projects is preferred More ❯

stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies Maintain and enhance compliance documentation (SOPs, policies, validation More ❯

stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies Maintain and enhance compliance documentation (SOPs, policies, validation More ❯

stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies Maintain and enhance compliance documentation (SOPs, policies, validation More ❯

stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies Maintain and enhance compliance documentation (SOPs, policies, validation More ❯