QA Validation Specialist – Equipment, Utilities, 6 mth contract
Test Triangle · Cashel, The Municipal District of Cahir — Cashel, Ireland
IT Services and IT Consulting · 51-200 employees
About the role
The QA Validation Specialist will oversee the qualification of equipment, facilities, and computerized systems to ensure regulatory compliance. They will also lead investigations into qualification deficiencies and support internal and external audits.
What they look for
Requirements
Candidates must hold a Bachelor’s degree in Science or Engineering and possess at least 5 years of experience in a pharmaceutical QA validation role. A strong understanding of EU and FDA regulations, data integrity, and validation lifecycle principles is required.
Full description
QA Validation Specialist – Equipment, Utilities, 6 mth contract
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 are 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 computerized 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 computerized system qualification.
- Knowledge of Data Integrity, Good
Documentation Practice (GDP), and validation lifecycle principles.
- Excellent written and verbal communication,
organizational, and interpersonal skills.
- Demonstrated ability in protocol/report
writing, problem solving, and cross-functional collaboration.
- Eligible to work in Ireland.
