GMP Documentation & Validation Specialist

PSC Biotech Corporation; The Municipal District of Dundalk; On-site; EUR 32,000 - 52,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a documentation specialist to review, organise and digitise archived validation documentation while supporting a new archival system for retrospective and prospective records. The role ensures paper records are converted to compliant electronic copies, with focus on data integrity and regulatory compliance.

Ideal candidates will have a science/engineering/quality background, experience in regulated environments, and strong organisational and communication

Qualifications

• Bachelor or equivalent in science/engineering/quality or related discipline.
• Experience in pharmaceutical or regulated quality environment.
• Knowledge of GMP, GDP and data integrity requirements.
• Understanding of validation lifecycle documentation and CQV processes.
• Strong documentation, organisational and communication skills.
• Experience with document archival, digitisation or electronic document management systems is desirable.
• Able to multi-task in a fast-paced 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

Document management

Organisational skills

Communication skills

Education

BSc in Science/Engineering/Quality

Tools

Electronic Document Management Systems

Job description

PSC Biotech Corporation in Ireland seeks a documentation specialist to review, organise and digitise archived validation documentation while supporting a new archival system for retrospective and prospective records. The role ensures paper records are converted to compliant electronic copies, with focus on data integrity and regulatory compliance.

Ideal candidates will have a science/engineering/quality background, experience in regulated environments, and strong organisational and communication