Overview
Role: QA Validation Specialist – Equipment, Utilities
Role Type: 12 month 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
Review and approve qualification and requalification protocols (IQ/OQ/PQ) forequipment, systems, facilities, and plant utilities.
Support and oversee execution of qualification activities, including area and drawingwalkdowns 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, andcomputerized system validation (CSV) activities, including data integrity compliance.
Lead investigations into qualification-related deficiencies and drive corrective andpreventive actions.
Approve calibration, preventive maintenance (PM) activities, and associated workorders for qualification activities
Support internal and external audits (e.g., FDA, HPRA) and ensure ongoing auditreadiness.
Promote continuous improvement initiatives within validation and contribute toperformance KPI reporting.
Assist with training of QA and validation personnel and maintain validationdocumentation and archive systems.
Education & Experience:
Bachelor’s degree in Science or Engineering (or equivalent) with 5+ years ofexperience 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.
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