20+ years of extensive leadership experience in the pharmaceuticals and biopharmaceuticals industry
 Detail knowledge of cGMP, Sterile-Ophthalmic, Injectables and Non-sterile – Nasal Sprays, Oral Solutions, Oral
Suspensions manufacturing and large-scale bulk manufacturing process including Microbiology laboratory operations,
Contamination Controls, trend analysis of various Microbiological Critical Quality Attributes
 Deeply participated leading USFDA, Health Canada Inspections, explaining various processes, investigations, and
Microbiology operations with satisfactory outcome
 Expertise in finding and writing deviations with thorough investigations, CAPA as per the cGMP, US-FDA and Health
Canada guidelines and expectations via Good Documentation Practices (GDP), Risk Assessments and Failure Mode
 Thorough knowledge on current cGMP and USP guidelines, Water systems (PW and WFI), Environmental Monitoring
 Worked in supervisory positions of a high volume, rapid turnaround Industrial Microbiology laboratory including 15
direct reports- High expertise in Sterility, Endotoxins, MLT’s and SOP’s and Work Instructions, Protocols writing.
 Proficient in using laboratory applications including SAP, LIMS, Trackwise, as well as MS Office.
 Proficient in OOS investigations and CAPA, Water Qualification study, Media Fill Qualification, Qualification of
Laboratory Instruments, Risk assessment for Sterilization process
 Ability to lead and manage investigations and non-conformances and act as a subject matter expert (SME) for routine
audits involving customers and regulatory authorities.
 Ready to take on assignments from Pharmaceutical/Bio-Pharmaceutical industries guiding and preparing them for
US-FDA, Health Canada inspections including WHO, EMEA agencies.
 Successful career track record for the Sterile/Non-Sterile Microbiology Laboratory testing, finding deviations,
implementing CAPA’s, Validations as per the USFDA, Health Canada, EMEA guidelines and expectations.