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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Associate QA Specialist (Shift)


Reference:AMC20711 Location: Carlow
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

Associate QA Specialist (Shift)
AMC20711
11 Months
Carlow



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




Duties:

  • 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.
  • Verification of the effective implementation of key GMP programs
  • Effectiveness of Preventative Actions
  • 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.
  • Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.


Education and Experience :
  • Third Level Degree qualified in a Science/Technical or related discipline.
  • 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

If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.