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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