QA Validation & Documentation Architect

PSC Biotech Corporation

Dundalk

On-site

EUR 32,000 - 52,000

Full time

3 days ago

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Job summary

PSC Biotech is seeking a detail-oriented documentation specialist to review, reconcile, organise, and digitise archived validation records within its Ireland quality team. You will help implement a new archival system, convert paper records to electronic True Copy formats, and ensure records meet GMP, GDP, and data integrity standards.

The role requires a BSc in Science, Engineering, Quality, or related discipline, plus experience in a regulated pharma environment and strong communication and

Qualifications

BSc in Science, Engineering, Quality, or related discipline.
Experience in a regulated pharma environment.
Knowledge of GMP, GDP and data integrity requirements.

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

Document management

Organisational skills

Communication

Education

BSc in Science/Engineering/Quality

Job description

The role requires a BSc in Science, Engineering, Quality, or related discipline, plus experience in a regulated pharma environment and strong communication and

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