Validation Administrator - 12 Month Contract
Basic Role Summary:
To provide administrative and documentation support to the Validation function, ensuring compliance with EU GMP, US FDA requirements, and company standards. This role is responsible for maintaining validation systems, supporting validation activities, and ensuring all documentation is accurate, controlled, and audit-ready.
Location: Onsite at our facility in Loughrea.
As our Validation Administrator, your key responsibilities will be as follows:
Maintain and administer the validation documentation system, ensuring records are accurate, current, and compliant.
Coordinate the preparation, review, approval, issuance, and archiving of validation protocols, reports, and related documentation.
Support validation activities for equipment, systems, processes, cleaning, and computerised systems as required.
Track validation schedules, milestones, periodic reviews, and revalidation activities.
Ensure compliance with internal quality standards, GMP, GDP, and regulatory requirements.
Manage change controls, deviations, CAPAs, and risk assessments related to validation activities.
Maintain validation master plans, matrices, logs, and status trackers.
Liaise with QA, Engineering, Production, IT, and other departments to ensure timely completion of validation deliverables.
Review completed validation packages for completeness, accuracy, and adherence to procedures.
Monitor document control processes, including version control and retrieval of validation records during audits and inspections.
Support internal and external audits by providing validation documentation and responding to queries.
Generate validation metrics, reports, and dashboards for management review.
Support training of personnel on validation procedures and documentation practices.
Identify opportunities for continuous improvement in validation systems and administrative processes.
Perform additional duties as required to support the Quality and Validation function.
Qualifications and Experience:
Leaving Certificate or equivalent qualification.
Further education or certification in administration, quality, or a scientific discipline desirable.
Previous administration or office support experience.
Experience in a regulated environment (pharmaceutical, medical device, manufacturing, or healthcare) desirable.
Experience with document control systems and record management advantageous.
Experience using databases or electronic systems preferred.
Basic understanding of document control and quality systems desirable.
Working knowledge of Microsoft Office (Word, Excel, Outlook).
Skills and Competencies:
Strong organisational and time management skills.
Excellent attention to detail and accuracy.
Ability to prioritise tasks and meet deadlines.
Effective written and verbal communication skills.
Ability to work independently and as part of a team.
Strong administrative and data entry capability.
Strong report writing skills.
Willingness to learn validation processes and internal systems.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
