QA Validation Specialist
Summary:
The QA Validation Specialist ensures that equipment, computerized systems, facilities, and utilities are qualified and maintained in compliance with regulatory, company, and quality standards. This role provides quality oversight, technical support, and continuous improvement input to sustain the site’s validated state.
Key Responsibilities
- 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.
- Support laboratory equipment qualification and review associated protocols and reports.
- Lead investigations into qualification-related deficiencies and drive corrective and preventive actions.
- Generate, review, and maintain Validation Master Plans, policies, and SOPs.
- Approve calibration, preventive maintenance (PM) activities, and associated work orders.
- Track and manage annual validation schedules, periodic requalifications, and associated risk assessments or studies.
- 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.
Qualifications and Requirements
- 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.
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