Description
CSV Consultant needed for a client based in Ireland for a 9 month + contract
The successful CSV candidate will have the following experience:
- Ensure all systems are qualified in compliance with Data Integrity policies and regulatory requirements.
- Co-ordination, direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Generation and maintenance of the Validation Master Plans.
- Generation and maintenance of Project Validation Plans.
- Generation of validation plans, protocols and final reports to cGMP standard.
- Review and approval of all protocols and final reports.
- Management of validation change control process.
- All other CSV and validation duties as required