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: Bachelors 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.
Bachelor’s degree in Science or Engineering (e.g., Chemistry, Microbiology, Mechanical, Electrical, or Chemical Engineering).
Minimum 5 years of experience in a pharmaceutical or biotech QA validation role.
Eligible to work in Ireland.
5+ years
Technical / Functional Skills Equipment & Utilities Qualification: Proficient in IQ/OQ/PQ protocol review, approval, execution, and requalification of equipment, systems, facilities, and plant utilities.
Computerized System Validation (CSV): Strong knowledge of GAMP 5, data integrity, and validation of computerized systems.
Regulatory Compliance: Deep understanding of EU GMP Annex 15, FDA 21 CFR Part 11, ICH guidelines, and audit readiness requirements.
Validation Lifecycle & Documentation: Skilled in creating/reviewing URS, SOPs, engineering drawings, protocols, reports, and maintaining validation archives.
Calibration & Maintenance Oversight: Ability to approve and oversee calibration, preventive maintenance, and associated work orders for qualified systems.
Deviation & CAPA Management: Lead investigations into qualification deficiencies, drive corrective/preventive actions, and ensure continuous compliance.
Audit Support: Experience supporting internal/external audits, ensuring regulatory compliance and documentation readiness.
Process Improvement: Promote continuous improvement within validation processes and contribute to KPI tracking.
Soft Skills / Interpersonal Abilities Analytical & Problem-Solving: Strong capability to interpret validation data, identify issues, and implement solutions.
Communication: Excellent written and verbal skills for reports, investigations, cross-functional interactions, and training.
Collaboration & Teamwork: Experience coordinating with production, engineering, QA, and validation teams.
Organizational Excellence: Efficiently manage multiple projects, maintain accurate documentation, and ensure compliance with GDP and ALCOA+ principles.
Training & Mentoring: Ability to train and guide QA and validation personnel in procedures and best practices.
Attention to Detail & Compliance Mindset: Rigorous adherence to regulatory requirements, company policies, and quality standards.