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 support a Technology Transfer/NPI programme and own the transfer documentation suite.

You will ensure documentation is controlled, traceable, compliant and inspection-ready, coordinating change controls and approvals, and maintaining trackers and dashboards. Experience in GMP documentation control, QMS and strong technical writing is required; knowledge of phase-gate reviews would be

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

Technical Writing

QMS/Document Management

Change Control

GMP Documentation

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.