Overview of your responsibilities:
- Support site validation and Quality Assurance activities.
- Execute equipment, utility, process and software validation to cGMP, FDA and GAMP standards.
- Prepare validation plans, protocols, schedules and reports.
- Support investigations, CAPAs and change controls.
- Oversee validation vendors.
- Execute autoclave, parts washer, lyo, CIP/SIP, VHP and temperature mapping validation.
- Review and approve validation documentation.
- Relevant degree with 5+ years’ validation experience.
- Strong autoclave validation experience.
- Aseptic process validation, including media fills and VHP.
- HVAC validation experience.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
