Excellent opportunity for a QA Specialist with a leading Life Sciences company. The role is located in the North West of Ireland and involves ensuring product manufacturing complies with GMP and regulatory standards.
About the Role:
* Provide technical expertise and guidance on QA and compliance topics, including validation strategy, new product introduction, and manufacturing issue resolution.
* Manage assigned QMS areas, including Deviation, Change Control, CAPA, audits, complaints, vendor management, and approval of batch records and production materials.
* Generate, review, and approve SOPs/documentation in designated areas.
* Review and approval of site procedures to ensure GMP and regulatory compliance.
* Review and approve validation protocols/reports to meet EU regulatory expectations.
* Maintain GMP/validation document review to support technology transfers and NPI.
* Apply Quality Risk Management principles as needed.
* Lead QA activities in project work-streams involving cross-functional teams.
Requirements:
* Third-level qualification in relevant science or engineering discipline.
* Minimum 5 years of experience in a GMP Quality environment.
* Experience in Validation function with strong knowledge of Project Life Cycle and cGMP.