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.
- 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.
