Sterility Assurance Specialist
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Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.
Your Key Responsibilities
Support and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.
Collaborate with Production, Engineering & Maintenance, MS&T, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.
Support the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.
Support deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.
Support the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).
Provide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.
Support technology
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