External Quality Assurance Specialist for API Manufacturing

1 week ago

Cork, Cork, Ireland beBeeQuality Full time €80,000 - €100,000
Job Summary:

The Senior/Principal Associate QA API External Manufacturing role is a critical position that supports all quality activities at Contract Manufacturing organizations.

This key position ensures that batches meet specifications, are manufactured in accordance with validated processes and comply with regulatory requirements.

Main Responsibilities:
  • Serve as a liaison between Contract Manufacturers and stakeholders.
  • Provide quality oversight of Contract Manufacturers including being the initial point of contact for all quality-related issues.
  • Evaluate and dispose API batches if necessary.

Applicants should possess a Bachelor's degree in a science-related field such as Pharmacy, Chemistry or Biological Sciences. Additionally, candidates should have five plus years of experience in GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QA.

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