Sterility Assurance Manager Global pharma Budapest

We are looking for a dedicated Sterility Assurance Professional who will be responsible for creating Sterility Assurance standards and ensuring compliance. This role involves generating reviewing and approving documentation to ensure adherence to corporate policies as well as current regulations and guidelines. Additionally the person will lead the development of the site's Sterility Assurance strategy and manage critical investigations.

Responsibilities:

• Develop and ensure compliance with Sterility Assurance standards
• Lead the development of the site's Sterility Assurance strategy
• Lead the implementation of the new Cleanroom Classification System (CCS) according to Annex 1
• Quality oversight of all factors related to ensuring the sterility of manufacturing
• Harmonize and standardize all aseptic practices onsite

Aseptic and Sterile Monitoring:

• Define and enforce regulations related to aseptic simulation processes
• Prepare environmental monitoring assessments and if necessary determine corrective and preventive actions
• Review and update the risk assessment of sampling points.
• Define and implement the identification strategy in collaboration with quality control

Operational QA/QC Sterility Leader:

• Utilize microbiological/asceptic technical knowledge and experience.
• Provide aseptic supervision at the operational level.
• Serve as an educational resource for Aseptic gowning cleanrooms microbiological knowledge and aseptic processes.
• Lead corrective and preventive actions related to sterility.
• Conduct selfaudits: visit and observe areas maintain contact with operational teams

Requirements:

• Appropriate qualifications and experience in Sterility Assurance
• Leadership and critical task management abilities
• Fluent in English and Hungarian
• Expertise in aseptic and sterile practices

If you are up for the challenge and want to be a part of a global pharmaceutical company's success please submit your application and resume.