Overview of your responsibilities (full job description available on request):
- Coordinate and manage the review, approval, and control of laboratory documentation.
- Drive documents through approval workflows to meet timelines and cGMP requirements.
- Serve as a key contact for laboratory documentation status and process updates.
- Support document management within laboratory documentation systems.
- Partner with cross-functional teams during NPI, technology transfer, and routine manufacturing activities.
- Ensure compliance with GMP, quality standards, and site procedures.
- Monitor and analyse laboratory performance and process metrics.
- Create, review, revise, and maintain SOPs, logbooks, forms, and other controlled documents.
- Support the preparation of reports, presentations, and documentation updates.
- Ensure laboratory documentation remains accurate, compliant, and inspection-ready.
- Bachelor’s degree in Science or a related field preferred.
- 1–3 years’ experience in a regulated laboratory or GMP environment.
- Experience in document control and records management.
- Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and Visio.
- Skilled in reviewing and editing controlled documents for cGMP compliance.
- Experience with electronic document management systems is advantageous.
- Proven ability to prepare, review, and approve GMP documentation to GDP standards.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
