Technical Documentation Lead — GxP & Veeva Expert

RECRUITERS; Cork; On-site; EUR 50,000 - 70,000; Full time

Job summary

RECRUITERS seeks an experienced Technical Writer to support laboratory operations through high-quality documentation, document management and training coordination with a focus on regulatory compliance and data integrity.

You will lead documentation strategy, draft SOPs and reports, ensure ALCOA data integrity, and act as SME for Veeva Quality Documents and ComplianceWire, collaborating with technical teams to translate requirements into precise documentation.

Qualifications

• Third-level qualification in a Science or Engineering discipline or extensive relevant experience in technical document writing.
• Proven experience in technical writing and controlled documentation, ideally in pharmaceutical, biotechnology, laboratory or regulated environment.
• Strong understanding of GxP, regulatory compliance, data integrity and ALCOA principles.
• Experience with document management or quality systems, ideally Veeva Quality Documents and/or ComplianceWire.

Responsibilities

• Lead and enhance the site’s documentation management strategy and technical writing processes.
• Develop, draft, review and approve SOPs, reports, forms and work instructions.
• Ensure documentation meets data integrity and regulatory compliance requirements, while being audience-appropriate.
• Act as SME for Veeva Quality Documents and ComplianceWire, guiding colleagues.
• Collaborate with SMEs and cross-functional teams to translate requirements into accurate documentation.
• Manage transitions of documentation into Veeva and initiate Change Requests when needed.
• Identify and implement improvements to writing processes and templates.
• Support training development by creating training materials and e-learning content in collaboration with Global Training.

Skills

Technical writing

Documentation control

GxP compliance

Veeva systems

Education

Science or Engineering degree

Tools

Veeva Quality Documents

ComplianceWire

Job description

RECRUITERS seeks an experienced Technical Writer to support laboratory operations through high-quality documentation, document management and training coordination with a focus on regulatory compliance and data integrity.

You will lead documentation strategy, draft SOPs and reports, ensure ALCOA data integrity, and act as SME for Veeva Quality Documents and ComplianceWire, collaborating with technical teams to translate requirements into precise documentation.