Senior QA Specialist

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. Ireland
Dublin
Posting date: 01 May 2019
QA.RH.23057_1556711483

An international pharmaceutical organisation is currently recruiting for a Senior QA Specialist based in Dublin. This company focus on developing treatments for conditions where the impact of the medicines can make an immediate and tangible difference. They provide treatments in Neuroscience, Rare Diseases and other medical sectors.

Job Responsibilities:

  • Maintain compliance of the company's Global Quality Standards against changing device and IVD regulations particular the EU MDR and IVDR and associated legislation.
  • Coordinate management reviews, post market surveillance, DHF audits and independent design reviews as required.
  • Support maintenance of product compliance to CE marking requirements.
  • Support EU medical device complaints including vigilance assessments.
  • Support day to day product quality including deviation and CAPA resolution, CMO management including supplier notifications of change and supplier corrective action reports and change controls.
  • Internal and external audit support including site readiness.

Skills and Requirements:

  • A university degree from a relevant field.
  • Demonstrable experience in a similar or relevant capacity.
  • Demonstrable project management skills.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Ronni Hartgen at +44 2038000814 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI RH2

#Compliance/Quality

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