Documentation & Compliance Specialist

Fastnet; Munster; On-site; EUR 45,000 - 60,000; Full time

Job summary

Fastnet is seeking a Documentation & Compliance Specialist for a 12-month contract in Tralee, Co. Kerry to own the transfer documentation suite and ensure it is controlled, traceable, compliant and inspection-ready.

You will support GMP documentation control, QMS, change controls and phase-gate readiness reviews, collaborating with cross-functional teams in a pharma/Life sciences environment.

Qualifications

• Typically 3+ years’ experience in GMP documentation control, Quality Systems or technical writing within pharma/life sciences.
• Strong technical writing skills with experience across QMS/document management systems and change control.
• Previous Technology Transfer, NPI or Validation programme experience would be highly advantageous.

Responsibilities

• Own and maintain the Technology Transfer document suite, including transfer plans, protocols and reports.
• Coordinate change controls, document approvals and traceability to source documentation.
• Maintain programme trackers/dashboards and support ongoing reporting.
• Support phase-gate document readiness reviews and audit/inspection readiness.

Skills

GMP docs control

Quality systems

Technical writing

QMS knowledge

Tools

Document management systems

Job description

Documentation & Compliance Specialist | 12-Month Contract | Tralee, Co. Kerry

Summary

A 12-month contract opportunity in Tralee, Co. Kerry for a Documentation & Compliance professional to support a major Technology Transfer/NPI programme. The role will take ownership of the transfer documentation suite, ensuring documentation is controlled, traceable, compliant and inspection-ready.

Key Responsibilities

• Own and maintain the Technology Transfer document suite, including transfer plans, protocols and reports.
• Coordinate change controls, document approvals and traceability to source documentation.
• Maintain programme trackers/dashboards and support ongoing reporting.
• Support phase-gate document readiness reviews and audit/inspection readiness.

Requirements

• Typically 3+ years’ experience in GMP documentation control, Quality Systems or technical writing within pharma/life sciences.
• Strong technical writing skills with experience across QMS/document management systems and change control.
• Previous Technology Transfer, NPI or Validation programme experience would be highly advantageous.