QP

Dublin North  ‐ Onsite
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Description

A global healthcare company is currently seeking a QP to work in their new site in Dublin.

Requirements:
  • Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive /EC & /EC and EU GMP Annex 16.
  • Assist in the coordination of the QA operational duties relating to product disposition.
  • Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
  • Ensure product release procedures comply with current regulatory and company requirements.
  • Ensure product periodic quality reviews are performed in timely manner and are reviewed and appropriate actions implemented.
  • Approve declaration of GMP for API's.
  • Ensure continued effectiveness of site Quality System through regular self-inspections and spot checks.
  • Review of results from on-going stability studies and ensure appropriate actions are implemented.
  • Review equipment qualification and process validation protocols.
  • Perform technical assessments of contract manufacturing facilities and equipment vendors.

Requirements:
  • Meets qualification requirements for a QP as listed in EU Directive /EC.
  • Previous experience of certifying medicinal product (previously or currently listed as a QP on an EU manufacturing licence).
  • 5 year plus quality experience in pharmaceutical industry encompassing manufacturing and packaging operations.
  • Working knowledge of EU and US GMPs
  • Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
  • Good team working and strong communication skills across functions and organization.
  • An ability to work flexibly in a changing environment.
  • Good attention to detail and priority management essential.


If you are interested in this great opportunity please apply below with an up to date CV.
Start date
06/2015
From
Real Staffing
Published at
06.05.2015
Project ID:
898935
Contract type
Permanent
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