Quality Assurance Specialist Lead

4 days ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time
Job Overview
Cpl Healthcare, in partnership with SK pharmteco, is seeking a Quality Assurance Lead Specialist on a 12-month contract to join the team in North Dublin. Our client is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities worldwide.

About Us

Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.

We are part of SK Inc., a Korea company with significant revenue.


Position Description

The Quality Team here at our facility are looking for a Quality Assurance Lead Specialist on a 12-month contract.

This role involves overseeing critical quality activities including New Product Introduction and Capital projects, maintaining key quality systems, and leading process validation studies.

This position also involves being the main point of contact from QA with customers, managing a portfolio of customer quality activities, ensuring adherence to Annual Product Review schedules, and participating in audits by regulatory agencies and customers.

  • Facilitating site investigations (including lab investigations)
  • Tracking investigations and CAPAs
  • Maintaining customer quality relationships

Additionally, the QA Lead Specialist addresses vendor non-conformances, and represents the company in customer meetings and cross-functional discussions.



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