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Senior Specialist

  1. Dublin
Dublin
  1. Contract
Competitive
  1. CAPEX Projects
05-05-2023
30776

This vacancy has now expired

Senior Specialist – Pharmaceuticals – Contract – Dublin

Are you looking for the chance to join a life changing pharmaceutical organisation in their mission to continuously drive innovation? We are recruiting for a Senior Specialist to support operations on their Dublin based site.   

Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation paves the way with state-of-the-art technology on their one-of-a-kind manufacturing facility. 

Senior Specialist Responsibilities:
  • Responsible for quality oversight of temperature-controlled product activities in all markets in accordance with local and international requirements
  • Ensure products shipments are managed in accordance with GDP’s requirements
  • Assess temperature-controlled shipments and provides corresponding quality decision on product.
  • Act as primary Quality technical contact point with distribution partners.
  • Provide guidance, drive and monitor Quality issues related to temperature-controlled products and GDP to resolution within the company and with external parties
  • Review documentation including change controls, deviations, validation documentation, SOPs and specifications
About you: 
  • Undergraduate degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering etc.)
  • Masters’ degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering etc.) preferred
  • QMS certification preferred
  • Minimum 5 years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
  • Thorough knowledge of temperature-controlled product activities
  • Thorough knowledge of cGMPs/GDPs and global regulatory requirements
Are you a good fit for this Senior Specialist position? We want to hear from you!

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

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