Microbiology leader with 29+ years of experience in leading global pharmaceutical, medical device, consumer healthcare industry, having proven track record of value creation through Microbiological Quality Excellence, Regulatory and Quality Compliance, Robustness and safety of products and Research microbiology.
Consistently demonstrated Microbiological Excellence across end-to-end Product Lifecycle (Product design for microbial safety, product release, trouble shooting, due diligence during M&A),positively impacting the business outcomes.
Skilled in US FDA and other regulatory compliance requirements. Experienced in audits for microbiology (Laboratories and manufacturing shopfloors), expert in data integrity for microbiology laboratory, Product preservation and associated micro stability testing, Product and RM risk assessment with controls, Rapid microbial methods for product release, Validation and monitoring of sterilization technologies (Steam, Gamma and EO), purified water system controls, HVAC and clean room requirements, microbiological product claims/demos, test method validations and suitability testing
