QA Validation Documentation Specialist

Orion Group; Carlow; On-site; EUR 38,000 - 56,000; Full time

Job summary

Orion Group Life Sciences is recruiting a QA Validation Documentation Specialist for a 9-month, 100% onsite contract in Carlow. You will focus on reconciling, digitising, and managing archived validation documentation, including rolling out a new archival system and Electronic True Copy processes.

The role requires a background in a regulated quality environment, with strong document management skills and knowledge of GMP/GDP and data integrity.

Qualifications

• 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.

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.

Skills

GMP knowledge

GDP knowledge

Data integrity

Validation lifecycle

Document management

Archival/digitisation

Education

BSc in Science/Engineering/Quality

Job description

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.

Peopleare our business worldwideOrion 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.