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Quality Auditor

  1. Midlands (Ireland)
Carlow
  1. Contract
Competitive
  1. Compliance / Quality Assurance
27-03-2024
33537
Quality Auditor - Pharma - Carlow, Ireland - 6 Month Contract + Possible Extensions

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Quality Auditor to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US. 


Role Summary:
  • Responsible for helping to ensure that the validated equipment on site maintains validated status. 
  • Act as quality support for validation and qualification activities of equipment, facilities, and associated processes on site to ensure they are maintained in accordance with global and local procedures. 
  • Ensure that quality issues are identified, addressed, and resolved in a timely manner.
  • Responsible for supporting deviation close out and initiating/following up on corrective and preventative actions.
  • Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project, basis including communications, training, project work, audit/inspection duties, investigations etc.

Requirement: 
  • Bachelor’s degree or higher preferred; ideally in a related Science discipline
  • Lean Six Sigma Methodology experience desired.
  • Demonstrated ability in pharmaceutical equipment validation/qualification or quality support for same
  • Knowledge of EU/US quality related pharmaceutical regulations
  • Experience of Sterile manufacture preferred.
  • Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or engineering roles.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics
  • Proven ability to effectively initiate and drive change.
  • Strong verbal and written communication skills, project management skills
  • Report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems)

If this role is of interest to you, please apply now! 
  #LI-CH3
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