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Manufacturing Investigation Lead

7 days ago


County Dublin, Ireland Recruitment By Aphex Group Full time

Job Description:

We are seeking an experienced Manufacturing Investigation Lead to join our team. As a key member of our quality assurance department, you will be responsible for leading investigations into manufacturing deviations and ensuring compliance with regulatory requirements.


Responsibilities:

  • Lead investigations into manufacturing deviations, including root cause analysis, development of CAPAs, and completion of product impact assessments.
  • Develop and implement process improvements to ensure compliance with regulatory requirements.
  • Communicate effectively with cross-functional teams and stakeholders, including presenting complex topics to large and small groups.
  • Collaborate with other departments to drive business objectives.


Requirements:

  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment