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Qualified Person

  1. Dublin
  1. Contract
Competitive
24910/NK
  1. Compliance / Quality Assurance
Date Posted05 Jun 2020

This vacancy has now expired

Global Biotechnology organisation requiring a QP to join their team! 

Dublin is a hub for the Life Sciences Sector at present with major global players investing in manufacturing facilities here. 

We are currently looking for a QP (Qualified Person) to join a Biotech facility on a contract basis. 

Most week you will be required 2 - 3 days on site, however this will occasionally need to be uplifted to 5 days; so flexibility is key. 

For this position, we are looking for someone based within Ireland (due to COVID-19 travel restrictions). You will also need to have at least 5 years experience in a Quality role within Pharma and minimum of 1 years experience as a QP. 

You will be responsible for: 
  • Principal certification of products prior to use in clinical trials and prior to release for sale and placing on the market.
  • Provide quality and compliance guidance on all critical and major quality matters.
  • Provide support to Regulatory for Regulatory submissions (IMPD, MAA) / QP declarations and License updates.
  • Creates an environment for ‘right first time’ in focusing on principles of lean, visual management and building in efficiencys as necessary from a systematic and compliance perspective
  • Review and approving of APQRs as required
  • Provide audit support as required for internal auditing program and supplier audits.
  • Maintain an up-to -date knowledge of pharmaceutical legislation and industry practice
For more information on this position, please apply with a copy of your CV today!

The candidate must have the rights to work in the location stated in the job advert.

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