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Qualified Person - Biologics Start-up

Job description

An exciting opportunity has arisen for a QP within a start-up pharmaceutical biologics facility in Dublin. Can you lead a team in manufacturing lifescycle sensitive regenerative medicine based product? Then this is for you!

Would you like to customize how you want to run QP operations? Well, here you can! This startup facility and is under the final stages of construction and your job will involve setting up the framework for the batch release of this novel (first of the kind) product.

The Product in this Job

First, of its kind, the exciting product which will be manufactured at this GMP site will be used to treat Chron's disease and is made up of mesenchymal stem cells. Once injected into the patient's colon these will facilitate regeneration of what was inflamed and damaged tissue.

Job Responsibilities

-Management of batch disposition and material status control.
-Review and record of essential documentation and SOPs.
-Provide support to QA team.
-Support both, the internal and external audits.
-Ensure compliance according to cGMP practices.
-Ensure compliance with specific regulatory frameworks.


Essential Job Requirements
-Primary Scientific degree.
-Education requirements to satisfy EU directive 2001/83/EC of a Qualified Person.
-5 years’ experience in QA, or similar.
-Currently practicing QP individual is desired, however a licensed QP not currently involved in batch release will also be considered.
-GMP knowledge as per FDA and EMEA regulation.

Should you be the qualifying candidate and are interested in this job, please contact Andrius at (01) 4744 692 or at andrius@sigmar.ie

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