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Satish Joshi

Partner

About Satish Joshi


Satish Joshi  is a Senior Consultant and Partner at QualiCulture Consulting Group Consultants who has over 28 years of experience in the pharmaceutical industry. He is a Quality Assurance and Quality Control professional experienced in sterile parenteral and solid oral dosage forms. He supports in setting up quality control laboratories and analytical quality assurance teams for finished dosage form and API (intermediates) manufacturing sites. He possesses a deep understanding of business strategy relating to quality assurance, quality control, CMC submissions, laboratory design and analytical development support. In addition he has provided expert scientific support for the timely resolution of issues raised by FDA.

EXPERTISE:

  • Served as a Quality Consultant for auditing, quality management system implementation and maintenance, training, corrective and preventive action, root cause analysis, management of change and vendor management.
  • Skilled Auditor certified in numerous disciplines and standards (ISO 9001, IPEC, ICH, FDA Good Manufacturing Practices and Good Laboratory Practices, UK MHRA, EMEA and PIC/S).  
  • Lead data integrity assessments in Quality Control laboratories
  • Propose / develop analytical methodologies and  update analytical methods: analytical method development, method validation / transfer, and method validation remediation
  • Compose / review laboratory deviation investigations (OOS, OOT, deviations) and change controls
  • Manage the qualification, preventive maintenance, and calibration of analytical instrumentation
  • Guide Quality Risk Assessment and CAPA implementation
  • Provide scientific guidance to resolve issues related to FDA 483 observations and Warning Letters
  • Auditing of Vendors and Quality Control Laboratories
  • Establish Quality Control Laboratory Systems and  Compose analytical laboratory SOPs
  • Implement laboratory data management systems 

EXPIRIENCE:

  • Senior Vice President - Head of Quality Assurance at Hospira Healthcare India Pvt. Ltd.
  • Vice President - Corporate Quality Assurance at Orchid Chemicals and Pharmaceuticals Ltd.
  • Various Head Roles in Quality Control, Quality Assurance and Compliance – Dr.Reddy's Laboratories Ltd. and Lupin Ltd.
  • Served as an independent GMP Consultant for Paraxel Inc.

EDUCATION:

  • Master of Science in Chemistry
  • Masters in Quality Management


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