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Quality Assurance Specialist

  1. Midlands (Ireland)
Carlow
  1. Contract
Competitive
  1. Compliance / Quality Assurance
01-07-2024
33211
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Quality Assurance Specialist -  Pharma - Carlow, Ireland - 11-Month Contract 

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

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:
  • Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
  • Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
  • Support the development and implementation of improved quality reporting measures.
  • Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
  • Provide effective real time on the floor support for day-to-day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
  • Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained.
  • Provide training in all aspects of Quality Management Systems and GMP.
  • Ensure all work is carried out in line with SOP’s, training, or other quality systems such as change controls where applicable.
  • Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.


Experience, Knowledge & Skills:
  • 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.
  • GMP Audit experience in the pharmaceutical industry
  • Third Level Degree qualified in a Science/Technical or related discipline.


If this role is of interest to you, please apply now! 

 #LI-CH3
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