QA Validation Documentation Specialist - 9 Month Contract

PSC Biotech® Corporation; Dundalk; On-site; EUR 29,000 - 42,000; Full time

Benefits offered by this job

9 Month Contract

Job summary

PSC Biotech Corporation is seeking a Documentation Archivist for a 9 month contract in Ireland. You will review, reconcile, and digitise archived validation documentation across multiple client sites, supporting the implementation of a new archival system and conversion to electronic records.

The role requires strong document management, understanding of GMP/GDP, and the ability to work in a fast-paced regulated environment.

Qualifications

• Bachelor-level degree or equivalent in a science/engineering/quality discipline.
• Experience in a pharmaceutical or regulated quality environment is desirable.
• Knowledge of GMP and data integrity requirements is important.
• Understanding of validation lifecycle documentation and CQV processes.
• Strong document management and organizational skills.

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 with CQV, Validation, and Document Control.
• Ensure compliance with GMP, GDP, data integrity, and site procedures.
• Support compliance reporting and quality system objectives related to documentation management.

Skills

Document management

Organizational skills

Communication skills

GMP/GDP knowledge

Attention to detail

Education

BSc in Science/Engineering/Quality

Tools

Document archival systems

Job description

PSC Biotech Corporation is seeking a Documentation Archivist for a 9 month contract in Ireland. You will review, reconcile, and digitise archived validation documentation across multiple client sites, supporting the implementation of a new archival system and conversion to electronic records.

The role requires strong document management, understanding of GMP/GDP, and the ability to work in a fast-paced regulated environment.