7 of 7 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 ...

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 ...

should have: 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence ...

should have: 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence ...

should have: 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence ...

Responsibilities Validate computerized systems in accordance with 21 CFR Part 11, EU Annex 11, OECD 17, and GAMP 5. Support CSV activities of the Quality Management System including deviations, CAPAs, and change controls related to GxP computerized systems. Review and create validation documentation - such as risk assessments, user requirements functional … years’ direct validation experience within regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, EU Annex 11, and GAMP 5 requirements. Demonstrated knowledge and experience with CSV, SDLC, and Data Integrity principles. Must be able to stay current with industry trends, regulatory changes, and best ...