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Quality Specialist

  1. NI & Ireland
  1. Contract
  1. Compliance / Quality Assurance
Date Posted11 Nov 2020
Quality Specialist – Dublin – 12-month contract

One of the top 10 best companies to work in Ireland is looking for more engineers for their large-scale new facility north of Dublin. Is this you?

Quality Specialist required to join a Global biotech company located in Dublin for an initial 12-month contract.

An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.

Essential Duties and Responsibilities for this Quality Specialist role include, but are not limited to, the following:
  • As the Quality Specialist you will be supporting the coordination of Quality events, Change Control and Market Complaints programs.
  • The Quality Specialist will provide Quality/Compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT Teams in support of new projects.
  • You will provide the necessary Quality support to the Global functional groups such as Global Regulatory/CMC and the local country Regulatory Manager in support of Regulatory Filings, Product Renewals and Regulatory Agency Questions.
  • You will assist in the preparation of Quality Agreements with the Third-Party Manufacturers and Alliance Partners along with reviewing the Annual Product Reviews submitted by the Third-Party Manufacturers.
Desirable Experience:
  • As the Quality Specialist you will be qualified to degree level in a Scientific Discipline such as Chemistry or Microbiology and have a minimum of 3 years’ experience working within the Pharmaceutical industry within the Quality Assurance department.
  • The Quality Specialist will have strong knowledge of cGMP Regulations pertinent to the USA, EU and other international markets.
  • You will have gained experience and technical knowledge of Chemical, Biological or Pharmaceutical operations with strong knowledge of Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs and Research Development.
 For more information on this position, please apply with a copy of your up to date CV today!

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

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