Is the SME for the Sterility Assurance topics in manufacturing units, approve the SOP's related to the subjects, support the Sterility assurance Ops specialists. * Approve aseptic summary of media sim; Approve or co-approve with the SAM the QMS gap analysis impacting Sterility Assurance topic (e.g. facility design) * Perform coaching/mentoring of operational/, provide Sterility Aseptic training, develop the competencies of the Sterility Assurance shopfloor. * Minimum 5-8 years of experience in GMP environment * Substantial knowledge of regulatory, GMP, sterile manufacturing, and * Expertise: aseptic practices/processes, material transfer, environmental monitoring of classified areas, gowning (incl. behaviors in classified areas) etc. * Strong knowledg
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