Pharmaceutical Sterility Assurance Specialist

5 days ago


Cork, Cork, Ireland GE Healthcare Full time

About the Job:

The Pharmaceutical Sterility Assurance Specialist will be responsible for the development and implementation of pharmaceutical sterility assurance programs across GE Healthcare’s Pharmaceutical Diagnostics business. This role will ensure compliance with regulatory requirements and industry best practices, with a focus on Annex 1.

Key Responsibilities:

  1. Develop and execute the pharmaceutical sterility assurance strategy, including the generation of new standardised processes and the roll out of pharmaceutical sterility assurance training.
  2. Manage the pharmaceutical sterility assurance COE team and mentor SMEs at manufacturing sites.
  3. Support regulatory inspections and internal audits, including responses and site pharmaceutical sterility assurance audits or reviews as necessary.
  4. Develop programs to continuously improve microbiology testing and test method validation, sterile barrier integrity, and environmental monitoring.
  5. Lead the knowledge increase of pharmaceutical sterility assurance to non-GxP personnel and develop continuous improvement processes to ensure the overall pharmaceutical sterility assurance program remains current and aligned to regulations.

Requirements:

  • Previous pharmaceutical sterility assurance experience and in-depth knowledge of cGMP requirements.
  • Demonstrated experience with applying quality & risk management tools and knowledge of regulations and guidelines.
  • Ability to comprehend and communicate key regulatory requirements and expectations.
  • Proven leadership skills and change agent with energy, passion, and enthusiasm to drive change.


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