Senior QA Lead

7 days ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time
About SK Pharmteco

SK pharmteco is a global CDMO with a long history of developing, scaling up and commercialising APIs and Chemical Intermediates.

Our facility in Swords has led the way in these activities for over 60 years.

We have made some of the world's most important medicines and continue to do so.


Responsibilities

The Quality Assurance Lead Specialist will oversee critical quality activities including New Product Introduction and Capital projects.

This includes maintaining key quality systems, leading process validation studies, and being the main point of contact from QA with customers.

This position involves 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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