QA Validation Specialist

Job Description

Job Spec for QA Validation Specialist – Equipment, Utilities
Location: Cashel, Tipperary
Summary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements, company policy and procedures. Support to Production/engineering to ensure the qualified state of equipment, systems, facilities and utilities is maintained.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Review and approve qualification and requalification protocols (IQ/OQ/PQ) for equipment, systems, facilities, and plant utilities.
• Support and oversee execution of qualification activities, including area and drawing walkdowns and vendor interactions (e.g., FAT)
• Review and approve related documents such as User Requirement Specifications, SOPs, drawings, and support files.
• Provide QA oversight and subject matter expertise on qualification, validation, and computerised system validation (CSV) activities, including data integrity compliance.
• Lead investigations into qualification-related deficiencies and drive corrective and preventive actions.
• Approve calibration, preventive maintenance (PM) activities, and associated work orders for qualification activities
• Support internal and external audits (e.g., FDA, HPRA) and ensure ongoing audit readiness.
• Promote continuous improvement initiatives within validation and contribute to performance KPI reporting.
• Assist with training of QA and validation personnel and maintain validation documentation and archive systems.

Education & Experience:

• Bachelor’s degree in Science or Engineering (or equivalent) with 5+ years of experience in a pharmaceutical QA validation role.
• Strong understanding of EU and FDA regulations related to equipment, facility, and computerised system qualification.
• Knowledge of Data Integrity, Good Documentation Practice (GDP), and validation lifecycle principles.
• Excellent written and verbal communication, organisational, and interpersonal skills.
• Demonstrated ability in protocol/report writing, problem-solving, and cross-functional collaboration.
• Eligible to work in Ireland.