As the QA Operations Lead at our client's site in Dunboyne, you'll be a pivotal member of the quality team, championing a strong compliance focus aligned with cGMP regulations. You'll be responsible for maintaining cGMPs across assigned areas, providing vital quality support, training, and guidance on company policies and regulatory requirements.
Your key accountabilities will include: leading cross-functional teams to resolve compliance issues and meet project goals, managing investigations and risk assessments, providing QA review/approval of GMP documentation (Change Controls, Deviations/CAPAs, SOPs), overseeing qualification/validation and technical transfers, and handling product disposition activities. You'll also evaluate new regulations, contribute to training development, and drive continuous improvement.
We're looking for a driven individual with:
- A Science/Quality/Technical degree.
- 8-10 years' experience in Quality Assurance, Quality Control, or Technical Operations within the Biological/Pharmaceutical industry.
- Project Management capabilities and a strong understanding of Operations.
- Proven expertise in QRM, Investigations, and Problem Solving as a Quality SME.
- Excellent written and verbal communication skills, strong attention to detail, and the ability to work independently and within a team.
- Experience with quality management systems (e.g., Veeva, SAP, PAS-X) and a thorough knowledge of FDA/EMEA regulations.
(Experience in direct regulatory agency interactions is highly desirable.)
