5 of 5 GAMP Jobs

process validation, equipment qualification.Develop validation master plans, protocols, risk assessments, and reports.Ensure regulatory compliance with FDA 21 CFR Part 11, GAMP 5, ISO 13485, and other standards.Partner with engineering, manufacturing, QA/QC, and operations teams to ensure validated state.Perform gap assessments, audits, and remediation of validation documentation.Oversee change control ...

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. ...

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 ...