Manufacturing Operations Lead

2 days ago


Dublin, Dublin City, Ireland Recruitment by Aphex Group Full time

About the Role

The Manufacturing Operations Lead will be responsible for leading investigations in a biotech/pharma manufacturing environment. This is a hybrid position, and the role requires strong technical knowledge of fill/finish operations.

Responsibilities

  • Manage deviation investigations, including establishing investigation teams and developing comprehensive compliant documentation.
  • Drive improvements to the investigation process and present findings to regulatory inspectors and internal auditors.
  • Coordinate and lead cross-functional teams through complex investigations.
  • Project management of the investigations end to end.
  • Present complex topics to large and small groups at various levels.

Qualifications

  • Bachelor's Degree in Science or Engineering with 5+ years of experience in a biotech/pharma manufacturing role.
  • Detailed technical understanding of fill/finish operations and compliance regulations.
  • Excellent technical writing and presentation skills.
  • Ability to manage multiple priorities in a fast-paced environment.

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