CSV
Location: Southern France (exact site location to be discussed)
Contract: 3-6 months (extension potential)
Working Pattern: Primarily onsite
Languages: Fluent French required
Overview
We are currently seeking experienced GMP Computer Systems Validation (CSV) Consultants to support a major pharmaceutical manufacturing programme involving the upgrade, implementation, validation and remediation of regulated computerized systems. This is a hands-on delivery role requiring consultants with experience executing validation activities, supporting system implementations, troubleshooting technical issues and working directly with site stakeholders throughout the project lifecycle. Candidates should have recent experience working within GMP-regulated environments and be comfortable supporting manufacturing, laboratory and quality systems.
Key Responsibilities
* Execute Computer System Validation (CSV) activities across GMP-regulated systems.
* Support the implementation, configuration, upgrade and remediation of computerized systems.
* Develop and execute validation documentation including URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrices and Validation Summary Reports.
* Perform functional testing, integration testing, User Acceptance Testing (UAT) and deployment activities.
* Support change controls, deviations, CAPAs and risk management activities.
* Troubleshoot system, configuration and integration issues.
* Work closely with Quality, Manufacturing, QC, Engineering, Validation and IT teams.
* Ensure compliance with GAMP 5, EU GMP Annex 11, 21 CFR Part 11 and Data Integrity requirements.
* Support implementation, cutover, startup and stabilization activities.
Preferred Experience
* Experience within pharmaceutical, biotechnology, vaccine, sterile manufacturing or other GMP-regulated environments.
* Hands-on experience with LIMS, MES, SAP, EBR, CDS, laboratory informatics platforms, manufacturing systems or quality management systems.
* Strong understanding of computerized system lifecycle and validation principles.
* Experience supporting system upgrades, migrations, remediation programmes and new system implementations.
* Knowledge of GMP regulations, Data Integrity, Annex 11 and 21 CFR Part 11 requirements.
* Recent hands-on configuration, testing, validation and implementation experience.
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