Summary
Overview
Work history
Education
Skills
Languages
Accomplishments
Certification
Timeline
Generic
Dinendra Singh Mewada

Dinendra Singh Mewada

Goa,INDIA

Summary

A Quality Assurance Professional with experience more than 18+ years in the top Pharmaceutical industries. Proven leadership skills involving, managing, developing and motivating teams to achieve their objectives. Dedicated to maintaining high quality standards and proven record of significant, successful contribution in quality management. Able to work on own initiative and as part of a team.

Overview

18
18
years of professional experience
6
6
years of post-secondary education
1
1
Certification

Work history

Executive Sr.Manager-Quality Assurance

INDOCO Remedies Ltd.
Goa , India
02.2023 - Current
  • Maintaining all aspects of the unit quality management by team of 70+ employees.
  • Generating new strategies and plans for improving quality of the products.
  • Implementation of cGMP practices in the facility and ensuring regulatory and audit compliance.
  • Quality Audits and system harmonization across all the manufacturing sites.
  • One point contact for required documents from unit for regulatory filing of products.
  • Batch releases for commercial distribution.
  • Handling of quality notifications, Non-conformances, OOS/OOT, Deviations, Change controls, CAPA (Root cause analysis) Tracking, Risk Assessment by using various tools.
  • Handling of Market Complaints, Investigation of root causes and implementation of corrective and preventive actions.
  • Vendor evaluation and qualification of raw materials, primary and printed packaging components
  • Vendor evaluation and qualification of raw materials, primary and printed packaging components.
  • Preparation of compliance report to the inspectional observations by regulatory / internal and vendor audits.
  • Media fill validation.
  • Handling of Process Validation.
  • Equipment’s and area Qualification.
  • Coordination with Production, QC, Warehouse and other cross functional departments for non-conformance and other tasks.
  • Identification of training need. Imparting training to the personnel and evaluating the skills.
  • Unit operation review.
  • Preparing and analyzing information for the purpose of management review.

Sr.Manager-QualityAssurance

INTAS Pharmaceutcals Ltd.
Ahmedabad, INDIA
11.2015 - 01.2023
  • Head of Oncology Injectable facility.
  • Batch releases for commercial distribution.
  • Shift Management.
  • One point contact for documents required for regulatory filing.
  • Media fill validation.
  • Timely execution of Validation and Qualification of equipment's as per Validation master plan.
  • Handling of Regulatory and internal inspections.
  • Performed Vendor audits for API's, Excipients and Primary packing components as per requirement.
  • Preparation of Compliance report for Audits.

Manager - Quality Assurance

Amneal Pharmaceuticals Ltd.
Ahmedabad, INDIA
01.2013 - 10.2015
  • Worked in green field project for Complex generics Injectable.
  • Preparation for SOPs and Protocols for Execution.
  • Planning and Execution of Area and Machine's Qualification such as Vial Washing, Tunnel Sterilizer, Autoclave, and Vial filling etc.
  • HVAC Qualification.
  • New Filling line's (Vial, PFS and Cartridge's) installation and Qualification.
  • Execution of Exhibit batches for Regulatory filing.
  • Coordination with various vendors and CFT Team to perform installation and qualification.
  • Vendor evaluation and qualification of raw materials, primary and printed packaging components.

Executive -Quality Assurance

Ranbaxy Laboratories Ltd.
Dewas Madhya Pradesh, INDIA
06.2009 - 12.2012
  • Worked in Dry Powder Injectable.
  • Preparation and review of Master BMR's/BPR's and SOP's.
  • Batch releases for commercial distribution.
  • Preparation of SOP's.
  • Handling of quality notifications, Non-conformances, OOS/OOT, Deviations, Change controls, CAPA (Root cause analysis) Tracking, Risk Assessment by using various tools.
  • Handling of Market Complaints, Investigation of root causes and implementation of corrective and preventive actions.
  • Preparation, review and Approvals of APQR's.
  • Identification of Training need and evaluation of skills.

Sr. Officer- Quality Assurance

Ipca Laboratories Ltd.
Ratlam, Madhya Pradesh, INDIA
12.2007 - 05.2009
  • Worked in Injectables and Solid Orals.

Management Staff

Cipla Ltd.
Goa , INDIA
04.2006 - 12.2007
  • Worked in Anticancer Injectables (Liquid and Lyophilised.)

Education

MBA - Operations

Institute of Management Studies DAVV INDORE
INDIA
07.2021 - 07.2023

Bachelor of Pharmacy - B.Pharm

School of PHarmacy DAVV INDORE
INDIA
07.2001 - 07.2005

Skills

  • Results-oriented
  • All time readiness for Regulatory Audits
  • Consistent compliance as per regulatory expectations
  • Regulatory filings of Products
  • Vendor development
  • Qualification and Validations
  • Leadership and Decision making
  • Innovative, Sincerity & performance
  • Ability to motivate staff and maintain good relations
  • Quality system development
  • Handling of Quality Management system

Languages

English
Fluent
Hindi
Fluent

Accomplishments

  • Successfully faced MHRA, USFDA, WHO,TGA, ANVISA audits etc.
  • Maintained all time readiness for regulatory and customer inspections.
  • Worked in green field project of Amneal Pharmaceutical’s Ahmedabad for Complex generics Injectables.
  • Implementation of electronic manufacturing system at INTAS pharmaceuticals Ltd.

Certification

  • Lead Quality Auditor- Certified by ISOQAR.

Timeline

Executive Sr.Manager-Quality Assurance

INDOCO Remedies Ltd.
02.2023 - Current

MBA - Operations

Institute of Management Studies DAVV INDORE
07.2021 - 07.2023

Sr.Manager-QualityAssurance

INTAS Pharmaceutcals Ltd.
11.2015 - 01.2023

Manager - Quality Assurance

Amneal Pharmaceuticals Ltd.
01.2013 - 10.2015

Executive -Quality Assurance

Ranbaxy Laboratories Ltd.
06.2009 - 12.2012

Sr. Officer- Quality Assurance

Ipca Laboratories Ltd.
12.2007 - 05.2009

Management Staff

Cipla Ltd.
04.2006 - 12.2007

Bachelor of Pharmacy - B.Pharm

School of PHarmacy DAVV INDORE
07.2001 - 07.2005

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