QA Validation Specialist – Equipment, Utilities, 6 mth contract
Full time | Test Triangle | Ireland
Posted On 29/10/2025
Job Information
Work Experience 5+ years
Medical
City Cashel
State/Province Tipperary
E25
Job 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.
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