Sterility Assurance Director Venezia

Sterility Assurance Director
Venezia
Veneto, Venezia

For an international pharmaceutical company, we are looking for a Sterility Assurance Director. The Sterility Assurance Director will be responsible for the Sterility Assurance Strategy, ensuring compliance with quality standards, GMP regulations, and industry best practices.

In this role you will manage a direct team, coordinate a multidisciplinary team and collaborate with other functions to ensure the microbiological integrity of sterile products. Key ResponsibilitiesDefine and implement the contamination control strategy, ensuring compliance with international guidelines (EU GMP Annex 1, FDA, ISO). Oversee and improve Environmental Monitoring (EM) programs, Aseptic Process Simulation (APS), sterilization validation, and cleanroom qualification. Ensure proper application of aseptic processing, sterilization, and microbiological risk management procedures. Lead preparation and management of regulatory inspections and internal/external audits. Provide technical support to production and quality departments in handling deviations, CAPA, and microbiological investigations. Promote continuous staff training on aseptic techniques, sterility, and contamination control. Assess and implement new technologies for improving sterility and aseptic processes. RequirementsDegree in Microbiology, Biotechnology, Chemistry, Pharmacy, or related fields. At least 10 years of experience in Sterility Assurance or Microbiological Quality Control, with at least 5 years in a leadership role. In-depth knowledge of GMP, Annex 1, FDA Guidelines, and international regulations for sterile production. Experience in managing sterile environments, isolator technologies, terminal sterilization, lyophilization, and aseptic filtration. Strong team management skills and the ability to interact with regulatory bodies. Problem-solving skills, microbiological risk analysis, and strategic leadership. Excellent communication and interpersonal skills to work with cross-functional teams and stakeholders.

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