Summary
Overview
Work History
Education
Skills
Languages
Additional Information
Timeline
Generic

MANISH KUMAR

Quality Assurance Manager
Shilpa Society, Nagpur,Maharashtra

Summary

Hardworking Quality Assurance Manager with 9.2 years of experience and having proficient knowledge in all QA operations, policies and procedures. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction. Accomplished at identifying deficiencies and initiating solutions to problems.

Overview

9
9
years of professional experience
12
12
years of post-secondary education
2
2
Languages

Work History

Quality Assurance Manager

Lupin Limited
Nagpur , Maharashtra
2016.05 - Current

LEAD ROLE

  • Leading a team (2 Executives) involved in preparation of Annual Product Quality Review .
  • Leading a team (3 Executives) involved in investigation of Market Complaint .
  • Leading a team (1 Sr. Executive and 6 Executives) involve in handling of Document Cell Management .
  • Leading a team (1 Sr. Executive and 1 Executive) involve in Commercial Batch Release and preparation of risk assessment report of Elemental Impurity and nitrosamine impurity .

REVIEW AND APPROVAL ROLE

  • Responsible for Quality Assurance review and approval of Change Control, Deviation, Market Complaint and Corrective and Preventive Action of site in Quality Assurance Management System .
  • Responsible for Site Audit Compliance and Global Compliance in coordination with other departments.
  • Responsible for timely initiation of Field Alert Report and Recall from site.
  • Responsible for presenting Site Quality Council Meeting to Management and finalize site presentation for Corporate and Global Quality Council Meeting.
  • Responsible for Quality Assurance approval of site Standard Operating Procedure .
  • Responsible for final approval of Commercial Batch Release from site.
  • Review and approval of Protocol and Report of Hold Time, Temperature Cycling Study and Transportation Study.
  • Review and approval of risk assessment report of Elemental Impurity and nitrosamine impurity.

ADDITIONAL ACTIVITY HIGHLIGHTS

  • Certified Internal auditor for Self-Inspection, Walk the talk Program and Vendor audit .
  • Certified Trainer and departmental training Coordinator .
  • Completed project for implementation of Document Cell Management System.
  • Leading the project for implementation of EDMS (Software for document preparation) at site.

Quality Assurance Executive

Lupin Limited
Jammu , Jammu and Kashmir
2012.11 - 2016.04
  • In-Process Quality Assurance activity in Manufacturing and Packaging process of OSD unit
  • Annual Product Quality Report preparation (Approx. 50 Products)
  • Process Qualification Protocol and Report preparation
  • Laboratory and Manufacturing investigation of Out of Specification and Out of Trend results

ADDITIONAL ACTIVITY HIGHLIGHTS

  • Handled the project of re-establishment of Cleaning Validation with new approach of Permitted Daily Exposure.
  • Performed Quality Risk Management of OSD Facility.
  • Performed vendor audit of API manufacturing site.

Education

M.Pharm - Pharmaceutical Chemistry

IIT-BHU (Banaras Hindu University)
Varanasi
2010.05 - 2012.08

B.Pharm - Pharmaceutical Sciences

Manipal University
Manipal
2006.04 - 2010.04

Elementary School Teaching

Jawahar Navodaya Vidyalaya (JNV)
Aurangabad, Bihar
1996.04 - 2002.03

Skills

    Microsoft Word and Excel

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Languages

English

Hindi

Additional Information

  • Regulatory Audit Exposure: USFDA-06 times, WHO-Geneva-02 times, MHRA, Ethiopia, Ukraine, Zazibona and other regulatory agency
  • Personal Information: Passport no.: U3632187, Date of Birth: 02 March 1984, Marital Status: Married

Timeline

Quality Assurance Manager

Lupin Limited
2016.05 - Current

Quality Assurance Executive

Lupin Limited
2012.11 - 2016.04

M.Pharm - Pharmaceutical Chemistry

IIT-BHU (Banaras Hindu University)
2010.05 - 2012.08

B.Pharm - Pharmaceutical Sciences

Manipal University
2006.04 - 2010.04

Elementary School Teaching

Jawahar Navodaya Vidyalaya (JNV)
1996.04 - 2002.03
MANISH KUMARQuality Assurance Manager