Role: QA Validation Specialist –
Equipment, Utilities
Contract: 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 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 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 work orders 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.