Documentation & Compliance Specialist
County Kerry, Munster, Ireland · Full Time · Mid Level · Posted
About the role
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.