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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

QA Associate Specialist - Shift


Reference:RK22685 Location: Carlow
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

QA Associate Specialist - Shift
RK22685
Contract – 11 months
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
  • Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
  • Provide quality oversight including training on all aspects of QMS and GMP and provide quality support for day to day operations
  • Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic 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 Rachel Kent at Life Science Recruitment for further information.