Onsite QA Operations Specialist - 11-Month Contract

PE Global; Leinster; On-site; EUR 65,000 - 80,000; Full time

Job summary

PE Global is recruiting for a QA Operations Specialist in Meath. The role supports clinical and commercial operations at the Dunboyne facility, driving quality, EHS, learning and continuous improvement while ensuring cGMP compliance.

You will liaise with site teams to resolve issues, manage quality systems, and ensure timely escalation when needed. A 11-month onsite contract with strong problem-solving focus is offered.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in biotechnology/pharmaceutical industry.
• Experience with deviation management/change controls.
• Knowledge of cGMP regulations and quality systems.

Responsibilities

• Provide QA oversight to clinical and commercial operations at the facility.
• Support quality management systems, CAPAs and change controls.
• Coordinate with Manufacturing Operations, MS&T and Engineering for daily operations.
• Ensure timely disposition of commercial Drug Substance and regulatory approvals.
• Represent Quality on multidisciplinary teams and drive continuous improvement.

Skills

QA oversight

Deviation management

Change controls

Batch Record Review

cGMP

Decision making

Teamwork

Initiative

Flexibility

Education

Science/Pharmacy degree

Job description

PE Global is recruiting for a QA Operations Specialist in Meath. The role supports clinical and commercial operations at the Dunboyne facility, driving quality, EHS, learning and continuous improvement while ensuring cGMP compliance.

You will liaise with site teams to resolve issues, manage quality systems, and ensure timely escalation when needed. A 11-month onsite contract with strong problem-solving focus is offered.