QA Validation Records Specialist
Days & onsite
RK26640
Contract 9 months
Louth


We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Louth. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role will support a strategic project focused on the reconciliation, digitisation, and management of archived validation documentation, including implementation of a new archival system and electronic True Copy process.



Key Responsibilities:

• Review, reconcile, organise, and digitise archived validation documentation.
• Support implementation of a new document archival system for retrospective and prospective records.
• Facilitate conversion of paper records to compliant Electronic True Copy records.
• Assess validation document completeness, criticality, and retention requirements.
• Support archive reorganisation activities in partnership with CQV, Validation, and Document Control.
• Ensure compliance with GMP, GDP, data integrity, and site document management procedures.
• Support compliance reporting and quality system objectives related to documentation management.

• BSc in Science, Engineering, Quality, or related discipline (or equivalent relevant experience).
• Experience within a pharmaceutical or other regulated quality environment.
• Knowledge of GMP, GDP, and data integrity requirements.
• Understanding of validation lifecycle documentation and CQV processes.
• Strong document management, organisational, and communication skills.
• Experience with document archival, digitisation, or electronic document management systems is desirable.