Sterility Assurance Leader — GMP Compliance & Strategy

Jefferson Wells; Latina; In loco; EUR 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies. The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments. Excellent English and strong technical leadership skills are required. This role offers an opportunity to work in a dynamic, multinational environment.

Competenze

• 5-10 years of experience in Sterility Assurance, Microbiology, or Quality Operations.
• In-depth knowledge of GMP, EU GMP Annex 1, and FDA/EMA guidelines.
• Hands-on experience with APS, aseptic processing, and environmental monitoring.

Mansioni

• Ensure implementation and maintenance of the Site Sterility Assurance Program.
• Support aseptic processing activities within sterile manufacturing.
• Collaborate to analyze and mitigate microbiological contamination risks.

Conoscenze

Microbiology

Sterility Assurance

Technical Leadership

Communication

Analytical Skills

Formazione

Master’s degree in a scientific discipline

Strumenti

TrackWise

Veeva

SAP-QM

Descrizione del lavoro

A leading pharmaceutical firm in Lazio, Italy, is seeking a Sterility Assurance Expert to ensure compliance with sterility processes and contribute to contamination control strategies. The ideal candidate will have a Master's degree and 5-10 years of relevant experience in sterile environments. Excellent English and strong technical leadership skills are required. This role offers an opportunity to work in a dynamic, multinational environment.