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Product Release and Compliance QA Specialist

Ref: 79194

  • 60,000-65,000
  • 20 Apr 2023
  • Offaly
  • Permanent

Product Release and Compliance QA Specialist

About the Company

Our client are a leading Global Healthcare group with multiple sites across Ireland. They develop, manufacture and supply a range of Pharmaceuticals, Biologics, Medical Devices and Diagnostics Globally. They have a presence in Ireland with multiple manufacturing operations and commercial offices. Due to success and expansion, they are looking to hire a Product Release and Compliance QA Specialist to join the team on site.

About the Position

This key member will play an important role in supporting the general site Quality Systems and look after the Batch Review and product compliance activities. This role will support the ongoing maintenance and continuous improvement of existing QA Process and Standard operating Procedures.

Key Responsibilities

  • Support the ongoing site training system

  • Review and approve Batch manufacturing records for Cell Culture and Purification operations to ensure cGMP compliance.

  • QA Documentation management and resolve any documentation issues as required.

  • Support change management, deviations, corrective and preventative actions.

  • ​​​​​​​Support Risk Management Procedures.

  • ​​​​​​​Provide QA Support to Quality Control.

  • ​​​​​​​Support Vendor management Operations with vendor assessments and auditing.

  • ​​​​​​​Prepare Quality agreements with required vendors.

  • ​​​​​​​Provide support with cell bank stability programmes, submission of samples and filing of results.

  • ​​​​​​​Manage specific projects as required.

  • ​​​​​​​Assist with supporting the qualification and period review of equipment.

  • ​​​​​​Liaise with internal departments such as QC, Production and Engineering.


  • Diploma in a Life Science discipline.

  • ​​​​​​​A Minimum of 3 years Biotech/Pharmaceutical QA Experience with a strong knowledge of cGMP.

  • ​​​​​​​Excellent attention to detail, interpersonal and communication skills.

  • ​​​​​​​Strong time management awareness and the ability to deliver projects against tight deadlines.

  • ​​​​​​​Excellent knowledge of regulatory and cGMP guidelines including Quality by Design and Risk Management.

Remuneration Package

Excellent Package on offer.
For more information on this position or other Life Science roles, please contact Miruna Holban on 01-592 7855 or hit the apply button below to send your cv. Alternatively, contact her directly via email;
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