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Details

QA Validation Records Specialist


Reference:RK26640 Location: Louth
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

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.


Education and Experience:
  • 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.


If interested in this posting, please feel free to contact Rachel Kent at Life Science Recruitment for further information.