Technical Writer

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

Technical Writer – Ireland, Cork – Initial 12-Month Contract – Life Sciences

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Our client is currently seeking a Technical Writer.

What You’ll Deliver

• Lead and maintain the Biologics CoE documentation management strategy, ensuring compliance, inspection readiness, and operational effectiveness.


• Author, review, and approve GMP documentation including SOPs, Batch Process Documents (BPDs), work instructions, protocols, reports, and forms.


• Act as SME for Veeva QualityDocs and ComplianceWire, providing system support, guidance, and training to stakeholders.


• Collaborate with cross-functional SMEs to develop accurate, compliant documentation and support document lifecycle management, including change controls.

What’s required:

• Bachelor's degree in Science, Engineering, Biotechnology, Life Sciences, or a related discipline, or equivalent combination of education and relevant experience.


• Proven experience in technical writing, document control, or quality documentation within a regulated pharmaceutical, biotechnology, biologics, medical device, or related industry.


• Strong understanding of GMP, GxP, Data Integrity, ALCOA+ principles, and regulatory compliance requirements.


• Experience working with electronic Quality Management Systems (eQMS) and Learning Management Systems (LMS), preferably Veeva QualityDocs and ComplianceWire.