Senior Manager Sterility Assurance

Alphapharm Pty Ltd T/A Viatris

Competitive salary; bonus scheme available; health...
Not specified (assumed hybrid based on industry standards)
Bachelor's degree in microbiology or related field
Extensive sterility assurance and aseptic manufacturing experience
Deep understanding of eu gmp annex 1 and global regulations
The Senior Manager Sterility Assurance position at Viatris focuses on ensuring the sterility of injectable products through effective contamination control and compliance with global regulatory standards. The ideal candidate will possess extensive experience in sterility assurance and microbiology, demonstrating strong leadership and collaboration skills while promoting a culture of quality

Job Summary

  • The Senior Manager Sterility Assurance plays a pivotal role in ensuring the sterility of injectable products through robust contamination control strategies.
  • This position requires leading the site sterility assurance program, developing Contamination Control Strategies, and conducting risk assessments for aseptic processes.
  • Viatris offers competitive salaries, excellent career progression opportunities, and an inclusive environment where employees can make a difference in healthcare.

Matching Summary

Match Score: 85

The Senior Manager Sterility Assurance position at Viatris focuses on ensuring the sterility of injectable products through effective contamination control and compliance with global regulatory standards. The ideal candidate will possess extensive experience in sterility assurance and microbiology, demonstrating strong leadership and collaboration skills while promoting a culture of quality.

Salary

Competitive salary; Bonus scheme available; Health insurance and pension included

Skills & Requirements

Must-have

  • Bachelor's degree in Microbiology or related field
  • Extensive sterility assurance and aseptic manufacturing experience
  • Deep understanding of EU GMP Annex 1 and global regulations
  • Proven contamination control strategy development expertise
  • Hands-on experience with isolator technology and environmental monitoring
  • Strong background in regulatory audits and inspection readiness

Nice-to-have

  • Ability to mentor and develop technical teams
  • Experience with MODA software and project management tools
  • Cross-functional collaboration skills across Quality and Engineering
  • Track record of driving continuous improvement initiatives

Key Requirements

  • Bachelor's degree in Microbiology or Biotechnology
  • Extensive years of experience in sterility assurance
  • Hands-on experience with regulatory audits
  • Knowledge of EU GMP Annex 1 and US/EMA GMP regulations

Work Rights

Not specified

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