Sanjay Sangale

Background

About Sanjay Sangale

Microbiology professional with 15+ years of experience in Pharmaceutical and Biopharmaceutical Quality Control (QC Microbiology) including sterile injectables, vaccines, biologics, and oral solid dosage forms.Currently working in a leadership role managing QC Microbiology laboratory operations, environmental monitoring programs, sterility assurance, and microbiological quality systems in GMP-regulated manufacturing facilities.Experienced in microbiology laboratory setup, greenfield project execution, facility qualification, water system validation, and regulatory compliance. Successfully handled and supported global regulatory audits including USFDA, MHRA, WHO, ANVISA, TGA and SAHPRA.Core expertise includes:• Environmental Monitoring Program Design• Sterility Testing, BET, Microbial Limit Testing• Water System Monitoring (PW/WFI)• Microbiology Lab Setup & Qualification• QMS (Deviation, OOS, OOT, CAPA, Change Control)• Validation & Qualification (IQ/OQ/PQ)• Cell Bank Handling (MCB/WCB)• Regulatory Audit Readiness• Cross-functional Team LeadershipPassionate about ensuring product quality, regulatory compliance, and continuous improvement in microbiological control strategies.Open to opportunities in QC Microbiology Leadership / Manager / Head – Microbiology roles within pharmaceutical and biopharmaceutical organizations.