Sterility Assurance - Executive/Manager - Goa

Sterility Assurance

Function with defined authority over intervention approval, APS design, EM programme design, and aseptic deviation closure

Preferred candidate profile & Role & responsibilities

Responsible for ensuring sterility assurance and contamination control across sterile formulation and aseptic manufacturing operations. The role shall have defined authority for approval of aseptic interventions, design and approval of Aseptic Process Simulation (APS), Environmental Monitoring (EM) programme design, and review and closure of aseptic deviations. Ensure compliance with applicable GMP requirements, contamination control strategy (CCS), and aseptic process validation standards.