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Contact Info
Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Quailty Specialist (Manufacturing Oversight)


Reference:AMC0003 Location: Louth
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Analyst

Quality Specialist (Manufacturing Oversight)
AMC0003
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.

Are you ready to engage in meaningful work that directly impacts product quality and patient safety?

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)

This role is initially six months with potential of extention based on performance and operational needs.

If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 693 0951 or [email protected] for further information.