Documentation & Compliance Specialist

Fastnet; Munster; On-site; EUR 45,000 - 65,000; Full time

Job summary

Fastnet in Tralee, Co. Kerry, seeks a Documentation & Compliance Specialist for a 12-month contract to support a Technology Transfer/NPI programme.

You will own the transfer documentation suite, ensure it is controlled, traceable, compliant and inspection-ready. Key duties include coordinating change controls, document approvals, maintaining trackers and dashboards, and supporting phase-gate readiness reviews and audits.

Qualifications

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

Quality Systems

Technical writing

Tools

QMS software

Document management systems

Change control tools

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.