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QA Specialist External CMO

  1. NI & Ireland
  1. Contract
  1. Compliance / Quality Assurance
Date Posted02 Feb 2021

This vacancy has now expired

QA Specialist – 12-month contract – Remote Working

As Dublin continues to embed itself as Irelands Pharmaceutical capital, we are seeking a QA Specialist to become part of a $500 million state of the art bio facility.

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

Essential Duties and Responsibilities for this QA Specialist role include, but are not limited to, the following:
  • As the QA Specialist you will serve as the SME for Drug Substance, Drug Product and Finished Product Manufacturing maintaining knowledge of industry standards and regulatory requirements.
  • The QA Specialist will provide oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
  • You will provide oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs.
  • The QA Specialist will work closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services.
Desirable Experience:
  • As the QA Specialist you will be qualified to degree level and gained a minimum of 2 years’ experience working as a QA Specialist within a cGMP environment.
  • The QA Specialist with have gained strong knowledge of industry best practice and current regulatory expectations concerning Drug Substance, Drug Product and Finished Product Manufacturing.
  • You will have strong experience working with Contract Manufacturing Organisations.
  • As the QA Specialist you will have vast experience with Risk Assessment and Risk Management.

If you feel you match these requirements and would like to know more about this fantastic opportunity then please apply now.

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

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