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GMP in Drug Stability, Drug Development and cGMP, FDA, and ICH Quality and Compliance Expert

Technical Consultant #2486


Expertise

  • Sterile, solid orals, liquid orals, dermal products; various dosage forms.
  • Managing strategic and operational performance of Quality Department providing:
  • Development and implementation,
  • Standardized quality system processes,
  • Review of standards for quality control,
  • Regulatory compliance,
  • Quality control systems and procedures (GLP).
  • Pharmaceutical industry (Formulations).
  • Quality Management System (QMS); Complaints, recalls, deviations, change control, OOS, OOT, CAPA, self-inspections, and annual product review.
  • Audits and compliance (Internal and external).
  • Third party audits Supplier and subcontractor audits.
  • Production management.
  • Validations (process; area; equipment; cleaning).
  • Policies and procedures.
  • Quality management and continuous improvement.
  • On site implementation of LIMS and LES; Learning Management System for employee training, Minitab software for APQRs.
  • ANDA Filings.
  • New projects; expansions.
  • Implementation of QRM and data reliability procedures.

Experience

Independent Contractor, Present

  • As lead consultant and deviation coach in association with Proclinical U.K. for the Pfizer Chennai (IKKT) site for training, development of the employees and investigations and closure of the QMS (deviations, change controls, events, quality assurance reports, field alert reports, etc.).

IPCA Laboratories Limited, Mumbai, India, Vice President Corporate Quality Assurance, 2015 - 2018

  • Recognized for successful audits of the formulation sites for various regulatory agencies including USFDA, WHO Geneva, Health Canada, Germany, Croatia, Colombia (INVIMA), TFDA, NAFDAC, SAMCC, Kenya, Zimbabwe, Ukraine, Russia, Belarus, Philippines, Uganda, UNICEF, etc.
  • Implemented corporate procedures (CSOPs) on various quality aspects for harmonization of the quality systems at all the manufacturing sites.
  • Reduced the rejection rate by more than 50% of the existing product complaints by streamlining the products / processes / systems through effective CAPA implementation.
  • Enhanced the automation there by implementation of various software in the quality system to reduce the mistakes done while manual working including Learning Management System for employee training, Minitab software for APQRs, Schedule manager software for effective scheduling of activities including stability sample management, etc.
  • Quality heads of the nine formulation units report to the undersigned for all the quality related matters.

Previous Positions, 1990 - 1992

  • Junior Production Officer in Parenteral Section (Liquid SVP)
  • Received approval in Small Volume Parenterals from Madhya Pradesh F.D.A., India.

Ingenus Pharmaceuticals, Mumbai, India, Head Quality Operations, 2011 - 2015

  • Performed quality operations and maintained them as per USFDA for its manufacturing sites in Switzerland and U.S.A. and eleven contract manufacturing partner locations in India and abroad.
  • Regulatory inspections.
  • GMP and Quality Management Systems as per quality and regulatory expectation
  • Implementing systems for meeting different quality standards and the relevant documents
  • Formulating and maintaining a Quality Risk Management system.
  • Main point of contact on all Quality matters, internally and externally; ensuring the development of SOPs (writing, revising and approving), Regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
  • Validations / Qualifications / Calibrations.
  • Quality Management System.
  • Training. 

Glenmark Generics Limited, Mumbai, India, Deputy General Manager CQA, 2008 - 2011

  • Documentation related to Pharmacopoeial amendments / revisions / implementation, vendor audits and approvals, internal quality audits, quality complaints, product recalls and returns management, technology transfer
  • cGMP compliance,
  • Product release, validations, stability studies, review and approval of CQAG

T3A Pharma, Assiut, Egypt as Head Quality Assurance, 2005 - 2008

  • Conducted audits for WHO Geneva, EU, ISO 9001:2000, ISO 18000, ISO 14000, Romania, Syria, and Iraq, GCC and other vendors.
  • Quality management as per ISO, HACCP, WHO, EU and FDA.
  • Master documentation review and approval.
  • Toll manufacture audits and approval.
  • Supplier audits and approval.

Ranbaxy Laboratories Limited, Dewas, India, Manager Quality Assurance, 2002 - 2005

  • Setting up of the QA infrastructure for contract manufacturing
  • Received Best Performer Bonus
  • Monitoring QA systems at more than 60 contract manufacturing sites.

Previous Position, 1992 - 1993  

  •  Production Supervisor in Solid Orals section        

Nicholas Piramal India Limited, Pithampur, India 1997 - 2002

Positions

  • Executive Solid Orals
  • Senior Executive Solid Orals
  • Manager Production Solid Orals
  • Manager Quality Assurance

Previous Position, 1993 - 1995

  • Junior Production Executive in Ophthalmic Section

Lupin Laboratories Limited, Aurangabad, India, 1995 - 1996

  • Senior Production Officer in Solid Orals (Capsules)

Honors & Publications


Credentials

 Competencies

  • Quality SOP & Strategy Policy Formulation
  • External and Internal Quality Audits
  • New Product Design
  • Process Improvement / Optimization
  • Client Relationship Management
  • Team Building and Leadership
  • Cost and Budget Management
  • Supplier Quality Assurance & Audit
  • Quality Management Systems
  • Microsoft Excel, PowerPoint, Word
  • Diploma in Pharmaceutical Production
  • Management from I.P.E.R. Pune

Languages 

  • English - fluent.
  • Hindi - fluent.
  • Gujarati - conversation.
  • Marathi - conversation.

Academic and Professional Affiliations

  • Member of ISPE
  • Member of PDA
  • Life Member - Indian Pharmaceutical Association
  • Member of GLG Council, UK.
  • Life member Chromatographic Society of India.
  • Study on Immobilization of Enzyme – Chymotripsin (Thesis)
  • Project Team for the implementation of MFG / PRO eB package
  • Project Team for the new block for solid orals
  • Core group during the preparation for ROCHE, SAMCC, IMB, IVAX approvals
  • Acted as an internal auditor for ISO 9001:2000 and 14001

Education

  • M.B.A. Human Resource Management, Institute of Management Studies, Devi Ahilya, India
  • M.S. Pharm The Department of Pharmaceutical Sciences, Sagar, India
  • B.S. Pharm   College of Pharmacy, Indore, India
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