Summary
Overview
Work History
Education
Skills
Audits exposure
Personal Information
Languages
Disclaimer
Timeline
Generic

Ratan Kumar Gautam

Dudahi

Summary

To work in a challenging and dynamic environment and to keep adding value to the Organization that I represent and serve to myself while concurrently upgrading my skills and knowledge.

Overview

11
11
years of professional experience

Work History

Executive

Macleods Pharmaceutical Ltd.
07.2021 - Current
  • Preparation of validation protocol and monitoring validation activities (process validation).
  • Compilation of process validation reports.
  • Preparation and compilation of Technology Transfer reports.
  • Monitoring and review of Hold Time studies, and compilation of reports.
  • Preparation of cleaning validation protocol and reports.
  • Preparation of new product Cross-Contamination checklist.
  • Preparation of new product introduction risk assessment.
  • Review of batch request form initiation of validation activities.
  • Monitoring of warehouse activities.
  • IPQA activities and monitoring, and exhibit of batches.
  • Ensure online documentation and its correctness.
  • Review of BMRs and BPRs.
  • Review of Annual Product Quality Review (APQR)
  • In-process sampling for semi-finished and finished goods samples.
  • Process validation sampling at different stages
  • Reporting and generation of non conformance report in case of any Non conformance occur related to product quality during the process
  • Online BMR review with audit trail, as well as batch report on a daily basis.
  • Review system audit trail and audit trail.
  • Release of finished product through SAP and ERP.

Executive

Zydus Healthcare Limited
11.2017 - 06.2021
  • Preparation of validation protocol and monitoring validation activities (process validation).
  • Compilation of process validation reports.
  • Preparation and compilation of Technology Transfer reports.
  • Monitoring and review of Hold Time studies, and compilation of reports.
  • Preparation of cleaning validation protocol and reports.
  • Preparation of new product Cross-Contamination checklist.
  • Preparation of new product introduction risk assessment.
  • Review of batch request form initiation of validation activities.
  • Monitoring of warehouse activities.
  • IPQA activities and monitoring, and exhibit of batches.
  • Ensure online documentation and its correctness.
  • Review of BMRs and BPRs.
  • Review of Annual Product Quality Review (APQR)

Executive

MAXCURE NUTRAVEDICS LIMITED (AKUMS DRUGS)
12.2015 - 10.2017

Executive

NEXT WAVE India (A MANKIND GROUP)
02.2015 - 12.2015

Executive

ALCHEMIST LTD.
06.2013 - 02.2015

Education

B.Pharma -

Anand College of Pharmacy
Agra, UP
01.2013

Intermediate -

L.M.I.C College
Kushinagar, UP
01.2007

Matriculation -

S.S.S.S.
Kushinagar, UP
01.2005

Skills

  • Monitoring of SCADA-based equipment
  • Monitoring of batch data in HMI-based equipment
  • MS Office
  • System Application Procedure (SAP)
  • ERP

Audits exposure

  • USFDA
  • TGA
  • CANADA
  • EUROPE
  • BRAZIL
  • UKRAIN
  • WHO (World Health Organization)
  • NSFS audit (National Standard Food Safety)
  • TFDA (Tanzania Food Drugs Authority)
  • Third Party Audit like Aventis, GSK, Merck, SUN Pharma etc.

Personal Information

  • Date of Birth: 11/08/91
  • Gender: Male
  • Nationality: INDIAN
  • Marital Status: unmarried

Languages

  • English
  • Hindi

Disclaimer

I hereby declare that the above-mentioned information is correct and I bear the responsibility for the correctness of the above-mentioned particulars.

Timeline

Executive

Macleods Pharmaceutical Ltd.
07.2021 - Current

Executive

Zydus Healthcare Limited
11.2017 - 06.2021

Executive

MAXCURE NUTRAVEDICS LIMITED (AKUMS DRUGS)
12.2015 - 10.2017

Executive

NEXT WAVE India (A MANKIND GROUP)
02.2015 - 12.2015

Executive

ALCHEMIST LTD.
06.2013 - 02.2015

B.Pharma -

Anand College of Pharmacy

Intermediate -

L.M.I.C College

Matriculation -

S.S.S.S.

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Ratan Kumar Gautam