Apotex Inc.
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.