Senior Quality Specialist

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Job Description

On behalf of our client, a pharmaceutical company, we are currently recruiting for a Senior Quality Specialist. This is a permanent full time role. The office is based in South Dublin but there is good flexibility to work from home a couple of days a week.

Responsible for setting up, maintaining and the continuous improvement of the quality management system as MAH.

 

  • Acts as the primary quality lead and management oversight for Quality all quality related activities on behalf of the Marketing Authorisation Holder
  • Development, management and implementation of the Quality Management System, including GMP & GDP systems, processes and SOP preparations.
  • Implemention and maintainance of Quality and Distribution Agreements with third parties, covering GMP, GDP and GCP acticvities
  • Providing quality advise to stakeholder departments in relation to GxP, covering commercial and development activities
  • Review and approve third party QMS documentation to ensure compliance with product authorisations and GxP requirements
  • Co-ordinate and review change controls
  • Manage and support third party audit management including CAPA
  • Review and assessment of deviations
  • Manage and review/approve the annual product review process
  • Support the preparation of Quality Management Reviews and Quality KPIs/metrics information.
  • Review documents assocaited with the manufacture and distribution of products manufactured by third parties, including, but not exclusively, batch manufacturing records, analytical records, validation activitity
  • Manage and participate in third party audits
  • Maintain tracking system for QMS documentation
  • Quality review of complaints
  • Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and regulatory requirements
  • Drive continuous improvement initiatives to enhance the MAH quality sytem and product quality ensuring compliance to governing regulations.

Act as the quality contact to customers and competent authority

 

Requirements

  • Degree in related Scientific Discipline
  • Min 3 years experience in a similar role
  • Solid experience in QMS
  • Ability to make quality decisions

For more information and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 278467

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Linda Dunne

Senior Recruitment Consultant ldunne@thornshaw.com
  • Salary:Negotiable
  • Location:Dublin City Centre
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-1910-439673_18