Pharmaceutical Lead Expert

1 week ago


Dublin, Dublin City, Ireland Cpl Resources Full time

We are seeking a Quality Assurance Lead Specialist to join our team at Cpl Resources, in partnership with SK pharmteco. This 12-month contract position is based in the Swords Campus, North Dublin, and offers an exciting opportunity to work with a global Contract Development and Manufacturing organisation (CDMO).

About Us:

SK pharmteco is a global leader in Contract Development and Manufacturing, with state-of-the-art facilities worldwide. As part of SK Inc., a Korea company with significant financial resources, we are committed to producing and delivering life-changing therapies that improve patient outcomes and save lives.

The Facility:

Located in Swords, Co Dublin, Ireland, our facility has been leading the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years. With a talented workforce and exceptional technical capabilities, we have made some of the world's most important medicines and continue to do so.

Key Responsibilities:

  • Lead critical quality activities, including New Product Introduction and Capital projects
  • Maintain key quality systems and lead process validation studies
  • Manage a portfolio of customer quality activities and ensure adherence to Annual Product Review schedules
  • Participate in audits by regulatory agencies and customers, facilitating site investigations and tracking investigations and CAPAs

Requirements:

  • Bachelor's or Master's degree in Chemistry or a related scientific field
  • Minimum 10 years of experience in the pharmaceutical industry, preferably in a Quality Assurance role
  • Strong initiative, ability to work independently and collaboratively within a team
  • Proficiency in API manufacturing from NPI through to commercialisation, cGMP principles, and regulatory requirements


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