Our client, a leading pharmaceutical company in Sligo are looking to hire a QA Validation Specialist on a 9 month contract initially.
- Review and approval of Validation Protocols (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
- Investigation and approval of deviations generated during qualification/validation testing.
- Participation in the project change control program and deviations for modifications to new and existing equipment.
- Act as the QAV lead in validation activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering and others.
- Resolve and assist in the closure of discrepancies initiated during Qualification execution.
- Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the change request documentation and the underlying documents for compliance.
- Implement and revise as applicable Quality Validation procedures.
- Conduct training in Validation Methodologies and related procedures as required.
- Minimum of degree qualification in relevant science and/or engineering discipline.
- 5 Years minimum. Experience with working in a regulated environment preferably within a Pharma/Biotech facility.
- 3 years in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations. Experience of ASTM E2500 would be a distinct advantage.
For a confidential discussion and more information on the role, please contact Mark Whelan.