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Qa Validation Documentation Specialist

Orion Group · Ireland · Posted 1 hour ago

Company Orion Group Location Carlow, Ireland Employment type Full-time Posted 1 hour ago Listed via Orion Group

Orion Group Life Sciences are currently recruiting a QA Validation Documentation Specialist on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 9 - Month contract with potential to extend. 100% Onsite 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.
Bring energy, knowledge, innovation to carry out the following:

  • 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.

What skills you will need:

  • 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.
  • Able to multi-task in fast-paced, dynamic working environment.

People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.

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