8 of 8 GAMP Jobs

compliance. Your Profile Experience with SAP or other enterprise systems, electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. ...

ensure successful implementation of smart factory and digital transformation initiatives. Ensure all solutions comply with relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5) and industry best practices. Client Engagement & Advisory: Act as a trusted advisor to clients, translating business challenges into actionable technical solutions. Conduct workshops, technical assessments ...

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 ...

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 ...

computer system validation policy, ensure alignment with current regulatory standards (e.g.: 21 CFR Part 11, OECD 17, OECD 17 supplement, EU – GMP Annex 11, GAMP 5) for Confidence Validation Services Maintain and update electronic systems, ensuring optimal performance and compliance Conduct risk assessments, compile compliance reports, manage deviations, and ensure … knowledge of QMS and eQMS Knowledge of CSV regulatory standards (eg.: OECD 17, OECD 17 supplement, 21 CFR Part 11, EU – GMP Annex 11, GAMP 5) would be beneficial Strong documentation skills and attention to detail Good communication and written skills and the ability to interact with other departments Ability ...

computer system validation policy, ensure alignment with current regulatory standards (e.g.: 21 CFR Part 11, OECD 17, OECD 17 supplement, EU – GMP Annex 11, GAMP 5) for Confidence Validation Services Maintain and update electronic systems, ensuring optimal performance and compliance Conduct risk assessments, compile compliance reports, manage deviations, and ensure … knowledge of QMS and eQMS Knowledge of CSV regulatory standards (eg.: OECD 17, OECD 17 supplement, 21 CFR Part 11, EU – GMP Annex 11, GAMP 5) would be beneficial Strong documentation skills and attention to detail Good communication and written skills and the ability to interact with other departments Ability ...

Must Have's: Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment. Familiarity with ISA 88, GAMP, cGAMP Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, automation C&Q activities. RESPONSIBILITIES Responsible for Software Development in DeltaV platform Conduct and oversee … manufacturing setting for Life Science industry Understanding of Process Automation implementation in a Pharma/Biotech environment. Familiarity with ISA 88 and GAMP Demonstrated skill with scripting and test automation. Clear understanding of Software Development Life Cycle (SDLC) and Agile methodologies. Qualifications Bachelor's or Graduate's Degree in engineering ...

work within a flexible, multi-skilled team to design, test, and implement PLC and SCADA/HMI solutions — ensuring compliance with GxP and GAMP standards. This hands-on position combines software design , system integration , and field service/commissioning both in the UK and internationally. Key Responsibilities Provide service, software … control systems for upgrade and retrofit projects. Manage data communications with third-party equipment and systems. Validate and document software designs in line with GAMP and pharmaceutical standards. Promote and implement Syntegon Telstar standard design practices to improve efficiency and cost-effectiveness. Provide remote and onsite technical support , including troubleshooting ...