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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Operations Specialist


Reference:RK1999 Location: Louth
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA 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.


Requirements:
  • 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)




If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.