QA Validation

Morgan McKinley; Dundalk; On-site; EUR 42,000 - 54,000; Full time

Job summary

Morgan McKinley is seeking a QA Validation Records Specialist for a 9-month, fully onsite contract in Ireland. The role focuses on reconciling, digitising, and managing archived validation documentation and implementing a new archival system.

You will convert paper records to Electronic True Copy records, assess documentation completeness, and ensure GMP/GDP/data integrity compliance across site procedures.

Qualifications

• Experience in 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

Quality environment experience

GMP GDP data integrity

Validation lifecycle CQV

Document management

Communication skills

Multi-tasking

Education

BSc in Science, Engineering, Quality, or related discipline

Tools

EDMS

Digitisation software

Job description

QA Validation Records Specialist - 9 Month Contract with potential extension- Fully 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.