GMP Technical Writer - Life Sciences

QCS Staffing; Cork; On-site; EUR 55,000 - 75,000; Full time

Job summary

QCS Staffing is partnering with a world-leading biopharmaceutical company in Cork to recruit a Technical Writer for an initial 12-month contract in Life Sciences. The role focuses on creating and managing GMP documentation to support regulatory readiness.

You will act as SME for Veeva QualityDocs and ComplianceWire, author and review SOPs, BPDs, and change controls, collaborating with cross-functional teams to ensure compliant, inspection-ready documentation.

Qualifications

• Bachelor’s degree or equivalent in a science or engineering field with exposure to regulated environments.
• Proven experience in technical writing, document control or quality documentation within pharma/biotech.
• Strong understanding of GMP/GxP, Data Integrity (ALCOA+) and regulatory compliance requirements.

Responsibilities

• Lead and maintain the Biologics CoE documentation management strategy, ensuring compliance and inspection readiness.
• Author, review and approve GMP documents including SOPs, BPDs, work instructions and forms.
• Act as SME for Veeva QualityDocs and ComplianceWire, providing system support and training to stakeholders.
• Collaborate with cross-functional SMEs to develop accurate, compliant documentation and lifecycle management.

Skills

Technical writing

Document control

Quality documentation

Regulatory compliance

Education

Bachelor's degree in Science, Engineering, Biotechnology, Life Sciences, or related discipline

Tools

Veeva QualityDocs

ComplianceWire

eQMS / LMS

Job description

QCS Staffing is partnering with a world-leading biopharmaceutical company in Cork to recruit a Technical Writer for an initial 12-month contract in Life Sciences. The role focuses on creating and managing GMP documentation to support regulatory readiness.

You will act as SME for Veeva QualityDocs and ComplianceWire, author and review SOPs, BPDs, and change controls, collaborating with cross-functional teams to ensure compliant, inspection-ready documentation.