Sterility Assurance Leadnew

Sterility Assurance Lead - Expanding Biopharma ManufacturerWe are seeking an experienced Sterility Assurance Lead to join an expanding biopharma manufacturer.
In this role, you will own the site's Contamination Control Strategy and ensure compliance with sterility assurance regulations.Key Responsibilities:Lead the site's Contamination Control Strategy.Collaborate with operations to develop a robust aseptic processing training programme.Establish the site's gowning strategy and oversee the cleaning and sanitisation programme.Monitor and analyse microbiological data to identify trends.Provide technical guidance on contamination-related non-conformances and events.Ensure compliance with sterility regulations and act as the SME for sterility assurance during regulatory inspections.Offer technical input for the transfer of microbiological test methods.Experience Required:Degree in a relevant technical discipline (Microbiology qualification desirable).Minimum 4 years' experience in Quality/Operations within the pharmaceutical or biopharma industry.At least 1 year of aseptic sterile fill-finish manufacturing experience.Experience in a microbiological function within an aseptic sterile fill-finish facility