Sterility Assurance Specialist

Job Description

• The primary purpose of this position is to ensure efficient and cost effective Sterility Assurance compliance.
  
• This includes developing, implementing, managing and continually improving Sterility Assurance activities to ensure that the facility is in compliance with current European and FDA requirements.

Roles/Responsibilities

• To be fully conversant with GMP requirements and changing requirements for site wide European and FDA Sterility Assurance Compliance in a parametric release environment.
  
• To identify, implement and provide guidance on improvement opportunities
  
• Help develop educational resources and optimise Sterility Assurance awareness throughout the site.
  
• To maintain up to date validation master files.
  
• Manage the Thermal Validation Schedule.
  
• Deputise for the Sterility Assurance Manager as required
  
• Present and defend Sterility Assurance data to auditors.
  
• To lead or participate in teams as required completing specific activities.
  
• Develop and implement a Sterility Assurance Internal Audit System on site.

Education / Professional Qualifications

• Third Level Qualification in Engineering / Science Discipline - essential.
  
• 
  

  At least 5 years Sterility Assurance compliance related experience in the pharmaceutical industry at a senior level including experience of dealing with regulatory bodies on Sterility.

For more information on this role, please contact Gemma Nesdale on (021) 2300302 or email: gnesdale@brunel.ie