Experience

Microrite, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Consultant

  • May 2014 - Present

  Microrite Inc. is a San Francisco/Bay Area based consulting and training firm serving Pharmaceutical, Medical Device, Drug-Device Combination Products, Biotechnology and In-Vitro Diagnostic clients. Microrite has expertise in the fields of Microbiology, Quality Control, Quality Assurance, Process Development, Process Validation, Facility and Utility Validation and Equipment Validation Microrite Inc. is a San Francisco/Bay Area based consulting and training firm serving Pharmaceutical, Medical Device, Drug-Device Combination Products, Biotechnology and In-Vitro Diagnostic clients. Microrite has expertise in the fields of Microbiology, Quality Control, Quality Assurance, Process Development, Process Validation, Facility and Utility Validation and Equipment Validation



MICROREMEDIZ

• Thane,India

• Technical Director

  • May 2012 - Feb 2015

  Microremediz is a state-of-art Microbiological Testing Laboratory located near Mumbai, India. We specialize in microbiological testing and analyze products from a wide variety of industries. Our microbiological testing facility is designed in compliance with c GMP standards and comprises of a highly experienced team of microbiologists who are experts in testing ASTM, AOAC, AATCC, FDA, EPA, USDA, USP, CTFA, JIS, ISO and other methods of analysis Microremediz is a state-of-art Microbiological Testing Laboratory located near Mumbai, India. We specialize in microbiological testing and analyze products from a wide variety of industries. Our microbiological testing facility is designed in compliance with c GMP standards and comprises of a highly experienced team of microbiologists who are experts in testing ASTM, AOAC, AATCC, FDA, EPA, USDA, USP, CTFA, JIS, ISO and other methods of analysis



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Incharge Microbiology Development Lab

  • Apr 2005 - May 2012

  Conducted Corporate GMP audits Part of internal audit team Set up standard documentation practices for the Microbiology laboratory. Microbiology Data Trending Trained on Bacterial identification systems - API , BBL Crystal, MIDI - Fame Microbial Limits test of Raw Materials and Finished Products as per USP/EP/BP/IP. Preservative efficacy determination of: Injectibles, Ophthalmic & Liquid Orals. Environmental monitoring of sterile areas and areas of manufacture of oral… Show more Conducted Corporate GMP audits Part of internal audit team Set up standard documentation practices for the Microbiology laboratory. Microbiology Data Trending Trained on Bacterial identification systems - API , BBL Crystal, MIDI - Fame Microbial Limits test of Raw Materials and Finished Products as per USP/EP/BP/IP. Preservative efficacy determination of: Injectibles, Ophthalmic & Liquid Orals. Environmental monitoring of sterile areas and areas of manufacture of oral dosage forms for Air Quality and Surface Quality. Microbiological Assay of Vitamins, Antibiotics. Sterility testing. Validations of autoclave and Dry heat sterilizer in Microbiology laboratory. Sound knowledge for performing DQ/IQ/OQ/PQ. Method Validation for Microbial Limit test, Sterility,Preservative efficacy test ,Antibiotic assay Documentation: Preparation and implementation of various Lab SOPs Knowledge of the following: US FDA requirements for Microbiology laboratory. WHO GMP requirements for manufacturing sites. EMEA norms. ICH guidelines Show less Conducted Corporate GMP audits Part of internal audit team Set up standard documentation practices for the Microbiology laboratory. Microbiology Data Trending Trained on Bacterial identification systems - API , BBL Crystal, MIDI - Fame Microbial Limits test of Raw Materials and Finished Products as per USP/EP/BP/IP. Preservative efficacy determination of: Injectibles, Ophthalmic & Liquid Orals. Environmental monitoring of sterile areas and areas of manufacture of oral… Show more Conducted Corporate GMP audits Part of internal audit team Set up standard documentation practices for the Microbiology laboratory. Microbiology Data Trending Trained on Bacterial identification systems - API , BBL Crystal, MIDI - Fame Microbial Limits test of Raw Materials and Finished Products as per USP/EP/BP/IP. Preservative efficacy determination of: Injectibles, Ophthalmic & Liquid Orals. Environmental monitoring of sterile areas and areas of manufacture of oral dosage forms for Air Quality and Surface Quality. Microbiological Assay of Vitamins, Antibiotics. Sterility testing. Validations of autoclave and Dry heat sterilizer in Microbiology laboratory. Sound knowledge for performing DQ/IQ/OQ/PQ. Method Validation for Microbial Limit test, Sterility,Preservative efficacy test ,Antibiotic assay Documentation: Preparation and implementation of various Lab SOPs Knowledge of the following: US FDA requirements for Microbiology laboratory. WHO GMP requirements for manufacturing sites. EMEA norms. ICH guidelines Show less



Monograph Development of United States Pharmacopoeia

• Advisory Panel Member For Antibiotic Chapter (2005 - 2010)

  • Apr 2009 - May 2010

  Was a part of Standard Setting procedure for USP CHapter <81> Was a part of Standard Setting procedure for USP CHapter <81>



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior QA Executive

  • Apr 2004 - Apr 2005



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Management Officer - Microbiology

  • Feb 1999 - Mar 2004



Indian Council of Medical Research (ICMR)

• India
• Government Administration
• 700 & Above Employee

• Research Technician

  • Jun 1998 - Feb 1999

  Elisa ,Gel Electrophoresis - Agarose and Poly Acrylamide DOT BLOT Sandwich test Protein Purification Revival , Propagations and Maintenance of cell lines DNA extraction Elisa ,Gel Electrophoresis - Agarose and Poly Acrylamide DOT BLOT Sandwich test Protein Purification Revival , Propagations and Maintenance of cell lines DNA extraction