QA Validation Specialist
Location: Cashel, Co. Tipperary
Reports to: Senior Manager, QA Operations
Type: Full-time, Permanent
Summary
You'll ensure all equipment, computerised systems, facilities, and utilities remain in a validated and compliant state.
You'll work closely with production and engineering teams to maintain the qualified status of systems in line with regulatory requirements and company procedures.
Key Responsibilities
1. Review and approve Qualification and Requalification protocols (IQ, OQ, PQ) for equipment, systems, facilities, and utilities.
2. Review and contribute to User Requirement Specifications.
3. Support the execution of qualification and requalification activities, including walkdowns of drawings and areas.
4. Liaise with vendors where required, including participation in FATs.
5. Review and approve drawings, SOPs, and supporting documentation.
6. Coordinate communication with production and engineering to ensure timely completion of validation tasks.
7. Provide QA oversight and regulatory advice on qualification, including CSV and data integrity.
8. Support qualification of laboratory equipment, reviewing and approving protocols and reports.
9. Lead investigations into qualification-related deficiencies and implement corrective actions.
10. Generate and execute project validation plans and master validation plans.
11. Prepare and review policies and SOPs related to validation.
12. Review and approve calibration and preventive maintenance schedules and work orders.
13. Track and manage the annual validation and periodic requalification schedules.
14. Support risk assessments, studies, and investigations related to qualification.
15. Participate in internal and external audits (HPRA, FDA) and maintain audit readiness.
16. Promote continuous improvement in validation systems and manage KPIs for management review.
17. Support internal self-inspections and maintain validation documentation and archives.
18. Provide training and support to new and existing staff.
19. Ensure all work is performed in line with procedural and timeline requirements.
Requirements
20. Bachelor's degree in Science or Engineering.
21. Minimum 5 years' experience in a QA Validation role within the pharmaceutical or biopharma industry.
22. Strong knowledge of EU and FDA regulations on Qualification, Validation, and Computerised Systems.
23. Understanding of Data Integrity and Good Documentation Practice (GDP).
24. Excellent protocol and report writing skills.
25. Strong communication, organisational, and problem-solving ability.
26. Capable of managing workload and meeting deadlines independently.
27. Must be eligible to work in Ireland
Apply: Contact Darren Brown —
#LI-DB4