Sterility Assurance Lead - Day shift (Monday to Friday 8:00-17:30)
Core
Lead Sterility Assurance and Environmental Monitoring programs to ensure compliance with regulatory and corporate requirements in a GMP environment.
Role type
Senior Sterility Assurance Lead
Builds
Sterility Assurance program and Environmental Monitoring systems
Domain
Healthcare manufacturing / Pharmaceutical GMP
Required skills
GMP knowledge, aseptic technique, environmental monitoring, regulatory compliance, cross-functional leadership, risk assessment, SOP management
Preferred skills
Cleanroom technical expertise, team leadership and mentorship
Responsibilities
Ensure compliance of Sterility Assurance program with regulatory and corporate requirements; Direct Environmental Monitoring program; Investigate and detail Sterility Assurance exceptions; Lead cross-functional teams in Environmental Performance Qualifications and Real Time Risk Assessments; Update and maintain Microbial Control Scheme and Plan; Ensure local SOPs are current and aligned with standards.