Founder and Managing Director

• May 2016 - Present

Pharma Knowledge Centre (PKC) “My Learning Life” is engaged to bridge the real-time knowledge gap between Academia and Industry to make Students “Industry Ready” for Pharmaceutical, Biopharmaceutical, and Clinical Research organizations. PKC offers specialized Quality Consulting, Training, Regulatory Compliance, and Quality Assurance for Pharmaceutical, Medical devices, Biotechnology, Food, and FMCG companies. We provide customized, value-added solutions, processes, and enhanced quality… Show more Pharma Knowledge Centre (PKC) “My Learning Life” is engaged to bridge the real-time knowledge gap between Academia and Industry to make Students “Industry Ready” for Pharmaceutical, Biopharmaceutical, and Clinical Research organizations. PKC offers specialized Quality Consulting, Training, Regulatory Compliance, and Quality Assurance for Pharmaceutical, Medical devices, Biotechnology, Food, and FMCG companies. We provide customized, value-added solutions, processes, and enhanced quality standards to optimize business process efficiencies and minimize regulatory risk. Show less Pharma Knowledge Centre (PKC) “My Learning Life” is engaged to bridge the real-time knowledge gap between Academia and Industry to make Students “Industry Ready” for Pharmaceutical, Biopharmaceutical, and Clinical Research organizations. PKC offers specialized Quality Consulting, Training, Regulatory Compliance, and Quality Assurance for Pharmaceutical, Medical devices, Biotechnology, Food, and FMCG companies. We provide customized, value-added solutions, processes, and enhanced quality… Show more Pharma Knowledge Centre (PKC) “My Learning Life” is engaged to bridge the real-time knowledge gap between Academia and Industry to make Students “Industry Ready” for Pharmaceutical, Biopharmaceutical, and Clinical Research organizations. PKC offers specialized Quality Consulting, Training, Regulatory Compliance, and Quality Assurance for Pharmaceutical, Medical devices, Biotechnology, Food, and FMCG companies. We provide customized, value-added solutions, processes, and enhanced quality standards to optimize business process efficiencies and minimize regulatory risk. Show less

Sr. Lead Quality Auditor, Expert and Associate

• Nov 2016 - Present

Lead Quality Auditor, Expert and Associate for Tier 1 21 CFR part 210/211, 21 CFR part 820, EU Vol. 4 - the Orange Guide, ICH Q7, IPEC Excipient GMPs, IPEC GDP, ISO 13485, ISO 17025, ISO 9001, WHO Guidelines, Tier 2 21 CFR part 11, 21 CFR part 58 (GLP), Canada GMP, EU Vol. 4 - Annex 11, GAMP 5, ICH E6, ICH Q10, PIC/S GMP Part 1, ISO 14001, ISO 15378, OHSAS 18001, SDLC Tier 3 21 CFR part 110, 21 CFR part 111, 21 CFR part 120 - HACCP, 21 CFR part 600, 21 CFR part 606, 21 CFR… Show more Lead Quality Auditor, Expert and Associate for Tier 1 21 CFR part 210/211, 21 CFR part 820, EU Vol. 4 - the Orange Guide, ICH Q7, IPEC Excipient GMPs, IPEC GDP, ISO 13485, ISO 17025, ISO 9001, WHO Guidelines, Tier 2 21 CFR part 11, 21 CFR part 58 (GLP), Canada GMP, EU Vol. 4 - Annex 11, GAMP 5, ICH E6, ICH Q10, PIC/S GMP Part 1, ISO 14001, ISO 15378, OHSAS 18001, SDLC Tier 3 21 CFR part 110, 21 CFR part 111, 21 CFR part 120 - HACCP, 21 CFR part 600, 21 CFR part 606, 21 CFR part 680, 21 CFR part 700, EFFCI, EU GDP, FSMA, HAZOP, ICH Q9, ISO 22000, PV/Adverse Events, ISO 10993, ISO 11135, ISO 11137, ISO 14971, ISO 22442, ISO 22716, ISO 27001 Tier 4 (Old Standards) API/ICH/FDA, Biologics/Biotech, Cosmetic/OTC, Excipient, GCP (Drugs/Devices), GDP - Good Distribution Practices, IPEC/Excipients, ISO 9001, Nutrition (CFR 110), Pharm Packaging/cGMP Q9, Repackaging/cGMP, Sterilization, AS 9100, API QI (Oil & Gas), ISO 13485/cGMP, ISO 17025/GLP, TickIT/Software, HSE Show less Lead Quality Auditor, Expert and Associate for Tier 1 21 CFR part 210/211, 21 CFR part 820, EU Vol. 4 - the Orange Guide, ICH Q7, IPEC Excipient GMPs, IPEC GDP, ISO 13485, ISO 17025, ISO 9001, WHO Guidelines, Tier 2 21 CFR part 11, 21 CFR part 58 (GLP), Canada GMP, EU Vol. 4 - Annex 11, GAMP 5, ICH E6, ICH Q10, PIC/S GMP Part 1, ISO 14001, ISO 15378, OHSAS 18001, SDLC Tier 3 21 CFR part 110, 21 CFR part 111, 21 CFR part 120 - HACCP, 21 CFR part 600, 21 CFR part 606, 21 CFR… Show more Lead Quality Auditor, Expert and Associate for Tier 1 21 CFR part 210/211, 21 CFR part 820, EU Vol. 4 - the Orange Guide, ICH Q7, IPEC Excipient GMPs, IPEC GDP, ISO 13485, ISO 17025, ISO 9001, WHO Guidelines, Tier 2 21 CFR part 11, 21 CFR part 58 (GLP), Canada GMP, EU Vol. 4 - Annex 11, GAMP 5, ICH E6, ICH Q10, PIC/S GMP Part 1, ISO 14001, ISO 15378, OHSAS 18001, SDLC Tier 3 21 CFR part 110, 21 CFR part 111, 21 CFR part 120 - HACCP, 21 CFR part 600, 21 CFR part 606, 21 CFR part 680, 21 CFR part 700, EFFCI, EU GDP, FSMA, HAZOP, ICH Q9, ISO 22000, PV/Adverse Events, ISO 10993, ISO 11135, ISO 11137, ISO 14971, ISO 22442, ISO 22716, ISO 27001 Tier 4 (Old Standards) API/ICH/FDA, Biologics/Biotech, Cosmetic/OTC, Excipient, GCP (Drugs/Devices), GDP - Good Distribution Practices, IPEC/Excipients, ISO 9001, Nutrition (CFR 110), Pharm Packaging/cGMP Q9, Repackaging/cGMP, Sterilization, AS 9100, API QI (Oil & Gas), ISO 13485/cGMP, ISO 17025/GLP, TickIT/Software, HSE Show less

Strategic GMP Consultant

• Dec 2016 - Present

Supporting the team for the preparation of PMDA, EMA, US-FDA, and other Regulated approvals. Supporting the team for the preparation of PMDA, EMA, US-FDA, and other Regulated approvals.

Strategic GMP Advisor

• Dec 2016 - Present

Sr. Global Auditor

• Aug 2016 - Present

Auditing and Oversight Services on Indian Manufacturers and suppliers in India for offshore clients. Assure of the requirements of 21 CFR 211 Auditing and Oversight Services on Indian Manufacturers and suppliers in India for offshore clients. Assure of the requirements of 21 CFR 211

Corporate Quality Head

• Apr 2015 - Apr 2016

Responsible for Corporate Quality Operations and Drug Regulatory Affairs across locations. Responsible for Corporate Quality Operations and Drug Regulatory Affairs across locations.

Vice President Quality

• Sep 2013 - Sep 2014

Responsible for Corporate Quality operations and Drug Regulatory Affairs. Successful implementation of global online complaint and query management system to ensure CAPA implementation and its effectiveness. Successful implementation of ERP system from WH to Dispatch including electronic batch control. Direct responsible for Improvement and harmonization of Quality of Policies, Processes and People. Champion of Six Sigma projects like First time right quality etc. CFR 21 110 &… Show more Responsible for Corporate Quality operations and Drug Regulatory Affairs. Successful implementation of global online complaint and query management system to ensure CAPA implementation and its effectiveness. Successful implementation of ERP system from WH to Dispatch including electronic batch control. Direct responsible for Improvement and harmonization of Quality of Policies, Processes and People. Champion of Six Sigma projects like First time right quality etc. CFR 21 110 & 111, FSMS, HACCP, ISO 22000, FSSAI regulations, BSI regulations, KOSHER, HALAL for Neutraceuticals. Certifications. Show less Responsible for Corporate Quality operations and Drug Regulatory Affairs. Successful implementation of global online complaint and query management system to ensure CAPA implementation and its effectiveness. Successful implementation of ERP system from WH to Dispatch including electronic batch control. Direct responsible for Improvement and harmonization of Quality of Policies, Processes and People. Champion of Six Sigma projects like First time right quality etc. CFR 21 110 &… Show more Responsible for Corporate Quality operations and Drug Regulatory Affairs. Successful implementation of global online complaint and query management system to ensure CAPA implementation and its effectiveness. Successful implementation of ERP system from WH to Dispatch including electronic batch control. Direct responsible for Improvement and harmonization of Quality of Policies, Processes and People. Champion of Six Sigma projects like First time right quality etc. CFR 21 110 & 111, FSMS, HACCP, ISO 22000, FSSAI regulations, BSI regulations, KOSHER, HALAL for Neutraceuticals. Certifications. Show less

General Manager Quality & Regulatory Affairs

• Jan 2012 - Sep 2013

Direct responsible for overall compliance and strengthening of Quality Assurance systems & procedures across the Organization including R&D. This involves Audit and compliance, Vendor qualification, knowledge sharing including Regulatory updates, Harmonization of systems & procedures, cGMP compliance, Training, support for Regulatory audits etc. for all formulation sites. Involved in several successful USFDA, MHRA, and WHO-Geneva and customer audits. Directly responsible for… Show more Direct responsible for overall compliance and strengthening of Quality Assurance systems & procedures across the Organization including R&D. This involves Audit and compliance, Vendor qualification, knowledge sharing including Regulatory updates, Harmonization of systems & procedures, cGMP compliance, Training, support for Regulatory audits etc. for all formulation sites. Involved in several successful USFDA, MHRA, and WHO-Geneva and customer audits. Directly responsible for negotiating with USFDA, CHMP and MHRA. Show less Direct responsible for overall compliance and strengthening of Quality Assurance systems & procedures across the Organization including R&D. This involves Audit and compliance, Vendor qualification, knowledge sharing including Regulatory updates, Harmonization of systems & procedures, cGMP compliance, Training, support for Regulatory audits etc. for all formulation sites. Involved in several successful USFDA, MHRA, and WHO-Geneva and customer audits. Directly responsible for… Show more Direct responsible for overall compliance and strengthening of Quality Assurance systems & procedures across the Organization including R&D. This involves Audit and compliance, Vendor qualification, knowledge sharing including Regulatory updates, Harmonization of systems & procedures, cGMP compliance, Training, support for Regulatory audits etc. for all formulation sites. Involved in several successful USFDA, MHRA, and WHO-Geneva and customer audits. Directly responsible for negotiating with USFDA, CHMP and MHRA. Show less

General Manager Quality & Regulatory Affairs

• 2007 - Jan 2012

Direct responsible for Harmonization of systems & procedures, Corporate Audit, cGMP compliance, Training, support for Regulatory audits, Vendor qualification etc. for all sites that includes Formulation plants, API plants and Biotech (API & Formulation) and R&D. Implementation and validation of SAP system across the locations. Preparation and evaluation of monthly quality trends for continuous improvements. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA… Show more Direct responsible for Harmonization of systems & procedures, Corporate Audit, cGMP compliance, Training, support for Regulatory audits, Vendor qualification etc. for all sites that includes Formulation plants, API plants and Biotech (API & Formulation) and R&D. Implementation and validation of SAP system across the locations. Preparation and evaluation of monthly quality trends for continuous improvements. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA and customer audits. Show less Direct responsible for Harmonization of systems & procedures, Corporate Audit, cGMP compliance, Training, support for Regulatory audits, Vendor qualification etc. for all sites that includes Formulation plants, API plants and Biotech (API & Formulation) and R&D. Implementation and validation of SAP system across the locations. Preparation and evaluation of monthly quality trends for continuous improvements. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA… Show more Direct responsible for Harmonization of systems & procedures, Corporate Audit, cGMP compliance, Training, support for Regulatory audits, Vendor qualification etc. for all sites that includes Formulation plants, API plants and Biotech (API & Formulation) and R&D. Implementation and validation of SAP system across the locations. Preparation and evaluation of monthly quality trends for continuous improvements. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA and customer audits. Show less

Head Quality

• Mar 2004 - Nov 2007

Directly responsible for Quality, Stability and Large Scale Validations to ensure all time audit preparedness. Preparation and evaluation of monthly quality trends for continuous improvements. Responsible to ensure Quality for the third party P to P and LLM business. Coordination and monitoring of CROs for various clinical studies. Directly responsible for Quality, Stability and Large Scale Validations to ensure all time audit preparedness. Preparation and evaluation of monthly quality trends for continuous improvements. Responsible to ensure Quality for the third party P to P and LLM business. Coordination and monitoring of CROs for various clinical studies.

Manager Quality & Regulatory Affairs

• Mar 2002 - Mar 2004

Responsible for overall QA/QC activities, QA Compliance. Involved in to support QA systems for Audits, restructuring of QA/QC and Training. Successful FDA audit, Restructuring and revision in JD of QA/QC. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA and customer audits. Responsible for overall QA/QC activities, QA Compliance. Involved in to support QA systems for Audits, restructuring of QA/QC and Training. Successful FDA audit, Restructuring and revision in JD of QA/QC. Extended support for several successful USFDA, MHRA, ANVISA, EDQM, local FDA and customer audits.

Head Quality

• Sep 2001 - Mar 2002

Set up R & D, QC, QA and Manufacturing Plant. Member of IBSC and obtained IBSC approval for the import of technology. Set up R & D, QC, QA and Manufacturing Plant. Member of IBSC and obtained IBSC approval for the import of technology.

.

• Sep 1998 - Aug 2001

Spearheading entire Quality activities for complete set up. Standardization of Indian system of medicine sponsored by Ministry of health Govt of India & Screening of natural isolates from soil & water for antibiotic activity. Spearheading entire Quality activities for complete set up. Standardization of Indian system of medicine sponsored by Ministry of health Govt of India & Screening of natural isolates from soil & water for antibiotic activity.

Visiting faculty for Biotechnology & Pharmacy

• 1998 - 2001

Visiting faculty Gujarat University Biochemical Engineering for PG courses. Visiting faculty Gujarat University Biochemical Engineering for PG courses.

Head Quality

• Jun 1994 - Aug 1998

Developed indeginious technology for Cyclosporin-A first time in India Set up R & D laboratory for microbiology & fermentation technology pilot plant (125 liter batch size) as per FDA. Culture improvement & strain purification, removal of heterogens & strain stabilization Development of culture maintenance techniques for long & short term storage Media optimization & use of Agricultural waste as media ingredients. Growth parameter optimization & sterilization methodology Seed… Show more Developed indeginious technology for Cyclosporin-A first time in India Set up R & D laboratory for microbiology & fermentation technology pilot plant (125 liter batch size) as per FDA. Culture improvement & strain purification, removal of heterogens & strain stabilization Development of culture maintenance techniques for long & short term storage Media optimization & use of Agricultural waste as media ingredients. Growth parameter optimization & sterilization methodology Seed development & production procedure, Inoculum optimization and incubation methods Standardization of incubation techniques & conditions, Sub culturing methods and microscopy Standardization of downstream unit operations and further upscalling according to batch size. Development of solvent recovery systems and reuse of recovered solvents. Chromatographic techniques and purification of final product as per USP standards. Development of application methods on HPLC system for continuous process monitoring, purity of Cyclosporin-A and impurity profile. Analysis of Cyclosporin-A on UV-VIS, FTIR, NMR, FABMASS, Optical rotation & elemental analysis. Beside R & D and production also involved in Equipment balancing and time scheduling GMP & GLP compliance for Building, Plant & Machinery, Man power, Equipment etc. Developed SOPs and project reports including project viability, profitability statement, economic feasibility of various projects of Aromatic Chemicals, Bulk Drugs, Drug Intermediates, Tissue Culture, Horticulture, Hybrid Seeds etc. Looked after the preparation of public issue, appraisals, prospectus, SEBI clearances etc. Liasioning with various Govt., Public & Private organizations for the implementation of the different projects. Looked after various regulatory affairs like pollution, Electricity, Water, Drug Licenses, Excise, Sales Tax, Explosive NOC, Land Conversion, SSI, SIA, IL, IEC registrations etc. for the various projects. Show less Developed indeginious technology for Cyclosporin-A first time in India Set up R & D laboratory for microbiology & fermentation technology pilot plant (125 liter batch size) as per FDA. Culture improvement & strain purification, removal of heterogens & strain stabilization Development of culture maintenance techniques for long & short term storage Media optimization & use of Agricultural waste as media ingredients. Growth parameter optimization & sterilization methodology Seed… Show more Developed indeginious technology for Cyclosporin-A first time in India Set up R & D laboratory for microbiology & fermentation technology pilot plant (125 liter batch size) as per FDA. Culture improvement & strain purification, removal of heterogens & strain stabilization Development of culture maintenance techniques for long & short term storage Media optimization & use of Agricultural waste as media ingredients. Growth parameter optimization & sterilization methodology Seed development & production procedure, Inoculum optimization and incubation methods Standardization of incubation techniques & conditions, Sub culturing methods and microscopy Standardization of downstream unit operations and further upscalling according to batch size. Development of solvent recovery systems and reuse of recovered solvents. Chromatographic techniques and purification of final product as per USP standards. Development of application methods on HPLC system for continuous process monitoring, purity of Cyclosporin-A and impurity profile. Analysis of Cyclosporin-A on UV-VIS, FTIR, NMR, FABMASS, Optical rotation & elemental analysis. Beside R & D and production also involved in Equipment balancing and time scheduling GMP & GLP compliance for Building, Plant & Machinery, Man power, Equipment etc. Developed SOPs and project reports including project viability, profitability statement, economic feasibility of various projects of Aromatic Chemicals, Bulk Drugs, Drug Intermediates, Tissue Culture, Horticulture, Hybrid Seeds etc. Looked after the preparation of public issue, appraisals, prospectus, SEBI clearances etc. Liasioning with various Govt., Public & Private organizations for the implementation of the different projects. Looked after various regulatory affairs like pollution, Electricity, Water, Drug Licenses, Excise, Sales Tax, Explosive NOC, Land Conversion, SSI, SIA, IL, IEC registrations etc. for the various projects. Show less

Head of Quality

• 1994 - 1998

Operations, Quality & and Drug Regulatory Affairs Operations, Quality & and Drug Regulatory Affairs

Scientist

• Jun 1989 - May 1994

Indo-US project entitled “ The role of interferon/ lymphokins in protection against malaria in the Rhesus monkey” Production and purification of interferon (for USP/DSP/Final filtration and impurity profiling/Fill finish operations/Analytics) Conversion of stationary cultivation technique of phage infected Aspergillus ochrasius to submerged stirred tank fermentation. “Development and field trial of Bacillus sphaericus mosquito larvicide in selected districts of U.P.” sponsored by… Show more Indo-US project entitled “ The role of interferon/ lymphokins in protection against malaria in the Rhesus monkey” Production and purification of interferon (for USP/DSP/Final filtration and impurity profiling/Fill finish operations/Analytics) Conversion of stationary cultivation technique of phage infected Aspergillus ochrasius to submerged stirred tank fermentation. “Development and field trial of Bacillus sphaericus mosquito larvicide in selected districts of U.P.” sponsored by U.P.C.S.T. Lucknow “Development of bioinsecticide from Bacillus thuringiensis and Bacillus sphaericus for controlling mosquitoes including disease vectors” Involved in the development of technology for l-lysine production. Involved in the transfer of l-Acetyl Phenyl Carbinol technology Show less Indo-US project entitled “ The role of interferon/ lymphokins in protection against malaria in the Rhesus monkey” Production and purification of interferon (for USP/DSP/Final filtration and impurity profiling/Fill finish operations/Analytics) Conversion of stationary cultivation technique of phage infected Aspergillus ochrasius to submerged stirred tank fermentation. “Development and field trial of Bacillus sphaericus mosquito larvicide in selected districts of U.P.” sponsored by… Show more Indo-US project entitled “ The role of interferon/ lymphokins in protection against malaria in the Rhesus monkey” Production and purification of interferon (for USP/DSP/Final filtration and impurity profiling/Fill finish operations/Analytics) Conversion of stationary cultivation technique of phage infected Aspergillus ochrasius to submerged stirred tank fermentation. “Development and field trial of Bacillus sphaericus mosquito larvicide in selected districts of U.P.” sponsored by U.P.C.S.T. Lucknow “Development of bioinsecticide from Bacillus thuringiensis and Bacillus sphaericus for controlling mosquitoes including disease vectors” Involved in the development of technology for l-lysine production. Involved in the transfer of l-Acetyl Phenyl Carbinol technology Show less

Assistant Professor

• Jul 1987 - May 1989

Teaching Post graduate and undergraduate classes. Teaching Post graduate and undergraduate classes.