Quality Operations Specialist

Quality Specialist (Manufacturing Oversight)
Contract – 6 months
Dundalk


We’re currently recruiting for an exciting project opportunity with a pharmaceutical manufacturing facility based in Dundalk.
We are looking for QA Specialists who are committed to enhancing product quality, reducing compliance risks, and improving regulatory audit readiness.


Key Responsibilities:

• Provide comprehensive oversight of the OSD filling line setup, operation, line clearance, and cleaning processes.
• Ensure all manufacturing operations adhere to standardized protocols for efficiency and compliance.
• Conduct routine inspections and batch record reviews to verify compliance with regulatory standards.
• Lead the investigation of deviations, implementing corrective and preventive actions (CAPAs) to ensure timely resolution, mitigate risks and prevent recurrence.
• Implement change controls, ensuring seamless integration of changes with minimal impact on production.
• Conduct training sessions for manufacturing staff to reinforce best practices, compliance, and efficiency in operations.
• Collaborate with a team committed to efficiency and teamwork, contributing to reduced downtime, increased throughput, and the maintenance of high-quality standards.

• Proven experience in the pharmaceutical industry (5+ years), with hands-on experience in manufacturing operations
• Strong understanding of quality assurance processes, including deviations, CAPAs, and change control management.
• Oral Solid dose experience (desired)