4 of 4 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 ...

system commissioning and deployment. Change Control & Compliance Ensure all updates and changes to laboratory systems and applications follow Change Control procedures . Adhere to GAMP guidelines, cGMP, 21 CFR Part 11 , internal policies, and external audit requirements. Ensure compliance with Computer System Validation (CSV), Data Integrity, and IT Security standards. ...

system design. The right candidate will have good prior ERP experience in the pharma industry, and exposure to key compliance areas e.g. GAMP, GxP, CSV. Your Responsibilities: Business Process Analysis: define requirements and translate to system configuration in the Oracle ERP system, and integrated systems Driving system improvements for Supply ...

beneficial. An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5. An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification ...