Experience

Wazoodle Fabrics LLC

• United States
• Textile Manufacturing
• 1 - 100 Employee

• Chief Storyteller and CEO

  • Aug 2012 - Present

  Bensalem, PA, United States Set the policies, strategy and direction for our family business, making sure we make safe, eco-friendly textiles with the mission of creating sustainable manufacturing jobs in USA.



Quality and Lean Management Consulting in Pharmaceutical, Medical Device, Tissue industries

• Principal Consultant

  • 2012 - 2014

  New Jersey, USA Providing help to companies in investigations, document control, CAPA systems, laboratory management, interpretation of FDA regulations and guidelines, water system problems, environmental monitoring systems and investigations, out of specification investigations, validation, answering FD-483 observations and warning letters.



Medtronic Inc

• Director Quality Systems

  • 2010 - 2012

  New Jersey Site lead for all Quality functions; Responsible for Quality Assurance, Quality Control and Quality Engineering; including Microbiology and Analytical laboratory management, Document Control, Auditing, Product Release, CAPA systems etc. - Participated successfully in the FDA pilot program for responding to inspection findings within 15 days with a well compiled response that resulted in closing the inspection. - Implemented policy deployment objective oriented management within the… Show more Site lead for all Quality functions; Responsible for Quality Assurance, Quality Control and Quality Engineering; including Microbiology and Analytical laboratory management, Document Control, Auditing, Product Release, CAPA systems etc. - Participated successfully in the FDA pilot program for responding to inspection findings within 15 days with a well compiled response that resulted in closing the inspection. - Implemented policy deployment objective oriented management within the quality group and met all the goals - Implemented systems for completing all laboratory tests within one business day of receiving samples and significantly decreased time to release. Show less



Osteotech

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Sr. Director Quality (Quality Assurance & Quality Control)

  • Nov 2009 - Jan 2011

  Responsible for all Quality Assurance and Quality Control activities: oversight & maintenance of all quality systems such as document control, change control, non-conformance reporting, corrective & preventive actions, internal and external auditing, supplier qualification, approval of risk assessments, validation protocols and reports, guide new product development teams in design control requirements etc.; Quality engineering, incoming material inspections , final product release; responsible… Show more Responsible for all Quality Assurance and Quality Control activities: oversight & maintenance of all quality systems such as document control, change control, non-conformance reporting, corrective & preventive actions, internal and external auditing, supplier qualification, approval of risk assessments, validation protocols and reports, guide new product development teams in design control requirements etc.; Quality engineering, incoming material inspections , final product release; responsible for Microbiology, Analytical and Sterility testing laboratories that perform in process and final product tests on all products, tests to support validation such as terminal sterilization validation by gamma irradiation and autoclave validation. Leading a highly effective team of Quality Engineers, QA professionals, Analysts and Microbiologists, QC and Product Release inspectors. Introduced performance metrics for the Quality functions and streamlined systems to significantly reduce lead time and reduce the cost of quality to the business. Successful in building highly effective teams by mentoring, training and motivating people to strive for excellence. Consistently achieved all assigned objectives and goals. Worked with the American Association of Tissue Banks and ISO Task force to define the standards for tissue based medical devices.

• Senior Director - Quality Control (& Sterile Control Operations)

  • May 2006 - Nov 2009

  Eatontown, New Jersey, USA Responsible for quality engineering, inspection, manufacturing and quality planning for new product development. Managing the non-conformance system and presenting CAPA analysis. Managing all laboratory operations, including development and validation of test methods for sterility, endotoxin, bioburden and analytical chemistry. Scheduling of operations for maintenance of clean rooms for aseptic manufacturing, sterilization of manufacturing supplies and terminal sterilization of… Show more Responsible for quality engineering, inspection, manufacturing and quality planning for new product development. Managing the non-conformance system and presenting CAPA analysis. Managing all laboratory operations, including development and validation of test methods for sterility, endotoxin, bioburden and analytical chemistry. Scheduling of operations for maintenance of clean rooms for aseptic manufacturing, sterilization of manufacturing supplies and terminal sterilization of products. Led process improvements in the Operations team to increase efficiency of processes, significant improvements in lead time and yield, and decrease the cost of quality. Created high performance teams, supported new product development for timely launch



Granules India Limited, Hyderabad, India

• General Manager

  • 2003 - 2004

  Responsible for Quality Assurance, Quality Control and Regulatory Affairs 100% Export oriented unit, manufacturing ready-to-compress granules of APIs like Acetaminophen, Metformin, Guaifenesin, in 6000 Kg batch size, supplying to customers in USA and Europe. Developed and implemented all quality systems in the unit, setting up the QC laboratory, validation/qualification of all equipment, GMP systems including document control, change control, internal audits, vendor approval, process… Show more Responsible for Quality Assurance, Quality Control and Regulatory Affairs 100% Export oriented unit, manufacturing ready-to-compress granules of APIs like Acetaminophen, Metformin, Guaifenesin, in 6000 Kg batch size, supplying to customers in USA and Europe. Developed and implemented all quality systems in the unit, setting up the QC laboratory, validation/qualification of all equipment, GMP systems including document control, change control, internal audits, vendor approval, process validation, water system validation etc. The unit was audited and approved by all customers in US, Canada and by the German Health Authority, Hamburg in January 2004 and by US FDA in May 2004, within a year of start up. Show less



Sri Krishna Pharmaceuticals Ltd

• Head - Corporate Quality Assurance

  • 2002 - 2003

  Hyderabad, India Responsible for Quality Assurance and Quality Control in multiple facilities