Skip to main content

QA Specialist External CMO

  1. NI & Ireland
  1. Contract
Competitive
26159/JS
  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.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website

Similar Jobs

Options: Contract
Location

Dublin 16

Description

Experienced Quality Assurance Validation Engineer/ Specialist required by a world leading biotechnology company in Dublin to support the introduction of multiple products (NPI) at their state of the

Options: Contract
Location

Dublin

Description

QA Specialist – 12-month contract - Dublin Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical

Options: Contract
Location

County Tipperary

Description

CSV Engineer – Contract – Ireland Our Partner in Tipperary area develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.