large Pharmaceutical client need an experienced CSV consultant to join their team to ensure Computerized System are validated and that all external and internal validation requirements are met and ensure CSV remains validated throughout their life cycle.
- Acts as QA authority in the assigned area of responsibility (specifically Manufacturing Execution System MES)
- Drive adherence to computer quality & compliance policies and guidelines
- Reviews and improves Computerized System Validation (CSV) documents and ensures adherence to internal and external guidelines
- Ensure QA requirements for IT systems are covered.
- Participate as subject matter expert for Compliance in Team meetings where necessary
- Strong knowledge in IT quality assurance and computer compliance demonstrated through management of projects in this area MES and/or SAP knowledge - NOT looking for a PM
- Significant experience in Computer System Validation is mandatory.
- Expert knowledge of appropriate regulations including CFR, Eudralex, and industry publications such as GAMP, ICH, PIC/S.
- Good knowledge in Good Manufacturing Practices and Quality Management System (QMS).
- Ability to summarize, write and present technical subjects to Senior Management.
- Ideally proven expereience of working in CSV for large projects
- XP Pharma mandatory (strict regulations in Pharma)
Homeworking, needs to be able to come to the client site when asked
- English fluent mandatory (all meetings in English)- French fluent mandatory
PLease send suitable Cvs ASAP