Excellent opportunity for a QA Specialist with a leading Life Sciences company located in the North West of Ireland. The QA Specialist ensures product manufacturing complies with GMP and Regulatory standards. Responsibilities include validating facility, equipment, and utilities, as well as reviewing and approving validation documentation. This individual contributor role requires a self-starter with expertise in QA and validation, facilitating collaboration with departments like Quality Control, Manufacturing, Engineering, and Technical Services.
Overview of your responsibilities:
- 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.
- Timely 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.
Knowledge, Skills and Experience Required for the Role:
- 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.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062