Sterility Assurance Expert- All genders

Vor 2 Tagen

Aubonne, Schweiz Merck Gruppe Vollzeit

Hiring Manager:Concetta Immacolata Pezzarossa

Recruiter:Caterina Del Vecchio

Location:Aubonne | Zone Industrielle de L'Ouriettaz

Department:HC-GM-QFUE Engineering Manager

Your Role

  • Participate on defining the site's Sterility Assurance strategy, ensuring compliance with aseptic processes and standards (e.g., GMP Annex 1).
  • Oversee and approve operational documents related to contamination control and sterilization processes.
  • Develop the Contamination Control Strategy in collaboration with all relevant departments.
  • Conduct risk analyses for aseptic processes and participate in Change Control evaluations.
  • Provide regulatory intelligence on sterility and aseptic practices.
  • Represent the site as a key subject matter expert to Health Authorities.
  • Collaborate on cross-functional strategic projects and engage with other sites producing sterile products.

Who You Are

  • Proven experience in sterility assurance and contamination control.
  • Strong knowledge of GMP regulations and aseptic processing standards.
  • Excellent analytical skills for environmental trend analysis and risk assessment.
  • Effective communicator with the ability to collaborate across departments.
  • Detail-oriented with a focus on compliance and quality assurance.
  • Skilled in developing and implementing contamination control strategies.
  • Experience in regulatory interactions.
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