Overview of your responsibilities (full job description available on request)
- Lead and support Quality Management System activities, including investigations, CAPAs, risk assessments, complaints, supplier non-conformances, and quality metrics.
- Review and maintain GMP documentation and SOPs to ensure compliance with site and global quality requirements.
- Act as Quality SME for incoming inspection, packaging, and QA operations.
- Oversee QA processes including line clearance, batch documentation review, artwork approval, and incoming inspection.
- Develop and deliver quality training to site personnel.
- Prepare quality reports and performance metrics for senior management and key stakeholders.
- Partner with cross-functional teams to implement quality initiatives and drive compliance improvements.
- Support internal audits, regulatory inspections, and external audits.
- Provide technical quality guidance across pharmaceutical and medical device operations.
- Lead or support quality activities for new projects, product introductions, and technology transfers.
- Mentor junior team members and provide leadership support when required.
- Act as Quality Manager delegate and support broader quality objectives as needed.
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
