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Details

QA Associate Specialist


Reference:AMC20711 Location: Carlow
Qualification:DegreeExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

QA Associate Specialist
AMC20711
Contract – 11 months
Shift role
On site - Carlow

We’re currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period.

Duties

  • Responsible for ensuring manufacturing of drug products is in compliance with cGMP and associated regulatory requirements
  • Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.
  • Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to customers.
  • Review and approval of batch documentation, SOPs, cleaning verification and validation data, training and other QMS documentation
  • Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations
  • Participate in Plant/Quality committees to help set the direction for plant wide GMP initiatives

Education & Experience

  • Third Level Degree qualified in a Science/Technical or related discipline.
  • GMP audit experience in pharmaceutical industry
  • Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
  • Report, standards, policy writing skills required.

If interested in this posting please feel free to contact Angela McCauley on +353876930951 or angela.mccauley@lifescience.ie for further information.





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