Quality Control Specialist (Co. Meath)

We are looking for a QA Operations Lead to join our team at BioNX, Dunboyne. In this role, you will ensure compliance with cGMP regulations, oversee quality assurance activities, and support continuous improvement at our biologics facility.

Key Responsibilities:

• Lead cross-functional teams on compliance and project milestones.

• Manage investigations, deviations, and risk assessments.

• Review and approve Change Controls, CAPAs, and SOPs for GMP compliance.

• Oversee product disposition and material release.

• Stay updated on regulatory guidance and implement necessary changes.

• Provide training and support quality improvement initiatives.

Requirements:

• Degree in Science, Quality, or a related field.

• 8-10 years’ experience in Quality Assurance or related roles in the biologics/pharma industry.

• Strong knowledge of FDA, HPRA, EMEA regulations.

• Experience with QMS systems (Veeva, SAP, PAS-X).

• Excellent attention to detail and problem-solving skills.

Location: Dunboyne
Industry: Biopharmaceuticals
Job Type: Full-Time