Sterility Assurance Expert

Buscojobs; Puglia; In loco; EUR 30.000 - 50.000; Tempo pieno

Descrizione del lavoro

Une entreprise de l'industrie pharmaceutique cherche un expert en assurance de stérilité à Lecce. Le candidat idéal possède un diplôme en microbiologie et une expérience en contrôle de contamination ainsi qu'en techniques aseptiques. Le rôle implique la participation à des projets transversaux et des déplacements fréquents en Italie et en Europe.

Competenze

• Expérience en qualification environnementale et stratégie de contrôle de contamination.
• Compréhension des bonnes pratiques de documentation et de la fonction générale de laboratoire de qualité.
• Capacité à travailler de manière autonome et à gérer plusieurs projets simultanément.

Mansioni

• Dirige l'évaluation de l'assurance de la stérilité dans l'industrie manufacturière réglementée.
• Participe à la rédaction de protocoles, rapports et spécifications.
• Exécution de la qualification des équipements de stérilisation.

Conoscenze

Aseptic technique

Contamination control strategy

Microbiological methods

Attention to details

Organizational skills

Ability to manage multiple projects

Good documentation practices

Formazione

Degree in microbiology, biology, biotechnology or science-related field

Descrizione del lavoro

Leads Sterility Assurance assessment in regulated manufacturing industry.

Experience in Environmental qualification and Contamination control Strategy.

Experience in aseptic process simulation risk assessment, validation strategy and oversight.

Experience in Contamination control strategy of pharmaceutical sterile products.

Execution of sterilizing equipment qualification.

Experience in microbiological and biological method application and validation.

Participates in cross functional projects, including customer meetings.

Participates in the writing of protocols, reports, and specifications.

Drives deliverables to completion with structured timelines.

Requested Qualifications :

Degree in microbiology, biology, biotechnology or science-related field

Understanding of good documentation practices and general quality laboratory function.

Ability to work independently and manage multiple projects simultaneously.

Strong attention to details, organizational skills and drive to be successful.

Experience with aseptic technique and biological safety cabinets.

Proficient in spoken and written English and / or a native language

Suitable candidates must be available for travel throughout Italy and some European travel may be required.

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Sterility Assurance Expert • lecce, Italia