Tech Transfer Documentation Lead (GMP Compliance)

LSC, Life Science Consultants

Munster

On-site

EUR 55,000 - 75,000

Full time

21 hours ago

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Job summary

LSC, Life Science Consultants in Ireland seeks a Documentation and Compliance Specialist to own the technology transfer/NPI documentation suite, ensuring traceability and audit readiness. You will coordinate change control, maintain document control dashboards, and support inspection readiness across programmes.

The role requires GMP documentation control experience, strong technical writing, and familiarity with QMS and EU GMP Annex 1 standards.

Qualifications

3+ years in GMP documentation control in pharma or life sciences.
Strong technical writing with attention to detail.
Experience with QMS, document management and change control.
Excellent coordination and stakeholder communication.

Responsibilities

Own the Technology Transfer/NPI document suite, including transfer plans, protocols, and reports, ensuring compliance with controlled templates and numbering conventions.
Coordinate change control, document approval routing, and maintain traceability back to source documentation.
Support transfer readiness reviews ahead of each phase-gate, ensuring documentation is accurate and complete.
Maintain transfer trackers and dashboards to support programme reporting.
Act as the primary contact for internal audits and inspections related to transfer documentation.