Excellent Validation Consultancy role to join a Leading Biopharma in Sligo on a 6 month rolling contract. The purpose of the project is to maintain and coordinate company's validation program in line with the site Validation Program. The ideal candidate will have experience with the full validation life cycle including IQ, OQ, PQ.
Overview of your responsibilities:
1. Validation of equipment, facilities, utilities, processes, and software in line with company policy, FDA, EU cGMP and GAMP requirements.
2. Create and maintain the Validation Master Plan.
3. Prepare and update Project Validation Plans.
4. Write validation plans, protocols, and reports to cGMP standard.
5. Apply risk-based qualification, including equipment risk assessments and critical test plan development.
6. Review and approve validation protocols and final reports.
7. Manage the validation change control process.
8. Follow and promote all EHS&E standards, policies, and procedures.
Knowledge, Skills and Experience Required for the Role:
9. Third-level qualification in a relevant engineering or scientific field.
10. 5–10 years' experience in a cGMP-regulated environment.
11. Strong understanding of regulatory expectations.
12. Practical experience executing IQ/OQ/PQ for facilities, utilities, or equipment within pharma, medical devices, or diagnostics.