· M.Sc. in Microbiology with 20 years of experience in Quality Control & Aseptic Assurance in sterile Injectables.· Expertise in handling a wide range of product portfolios like Sterile, Biologicals(mabs),LVP,SVP,Opthalmics,oral solids and liquids.· Core team member in the BLA submissions and query responses.· Played a vital role in implementing LIMS and managing environmental & water system monitoring, validation and its qualifications both in aseptic manufacturing facilities, ensuring regulatory compliance & facing regulatory audits· Establishing aseptic assurence and colabrating with CFT to define contamination control strategy.· Skilled in establishing a system of approaches to investigation procedures & building systems which ensure ‘robust' reportage from quality· Gained significant experience in various other aspects of project management/execution including new laboratory designing, budgeting, equipment and test method validation, etc.· Extensive exposure to regulatory audits of US FDA, MHRA, ANVISA, TGA, PMDA , EMEA etc..· Possess leadership skills including recognizing the strengths & weaknesses and willing to perform additional activities