Sterility Assurance Specialist

5 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno
: Support the Sterility Assurance Manager and the Sr Sterile Operations Manager in implementing the new Annex 1 guidelines, including conducting GAP assessments and FMEAs to evaluate the risk of microbial, pyrogen, and particulate contamination. Additionally, contribute to the development and implementation of the Contamination Control Strategy and CAPA plan. Evaluate Sterility Assurance topics related to new projects, such as new departments, manufacturing lines, and processes/products introduced. Assess aseptic practices and interventions to reduce the risk of aseptic manufacturing processes and sterile products. Collaborate with the QC Microbiological lab and Production teams to evaluate Environmental Monitoring data. Provide support for Sterility Assurance deviations and participate in regular oversight activities in the production department to improve and promote a culture of Sterility Assurance. Engage in discussions with clients regarding Sterility Assurance topics and contribute to client audits and regulatory inspections.

Requirements:

Equivalent experience in a relevant field will also be considered. Previous experience in the manufacturing of sterile medicinal products. Strong knowledge of aseptic processes, Sterility Assurance concepts, and microbiological notions. Excellent written and oral communication skills with the ability to interact effectively with all levels of management and personnel at the operating unit level. Ability to work collaboratively in cross-functional groups. Fluent understanding of Sterility Assurance guidelines. Proficient in spoken and written English. Strong problem-solving and stress management skills.

At Thermo Fisher Scientific Inc., we are committed to fostering an inclusive and diverse work environment. We are an equal opportunity employer and encourage qualified individuals from all backgrounds to apply. We are also dedicated to providing reasonable accommodations and adjustments for individuals with disabilities to ensure they have equal access to employment opportunities. Please let us know if you require any accommodations during the application process.

If you are an ambitious professional with a proven track record in Sterility Assurance, we invite you to join our exceptional team and contribute to our mission of enabling our customers to make the world healthier, cleaner, and safer.

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