Summary
Overview
Work History
Education
Skills
Accomplishments
Locationpreference - Locations
Personal Information
Languages
Hobbies and Interests
Disclaimer
Timeline
Hi, I’m

Suraj Bhagwatrao Bidwai

Suraj Bhagwatrao Bidwai

Summary

Result-oriented professional targeting challenging assignments in Quality Assurance (CSV) with an organization of high repute preferably in Pharmaceutical Industry

A competent professional with an experience of overall 8+ years in Computer System Validation (CSV) and Pharmaceutical Quality Assurance. Proficient in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge. A keen implementer with experience in providing support to projects for improving efficiency of automation & control using available resources & by installing suitable instruments as per requirement. In-depth knowledge on CSV, GAMP 5, data integrity and 21 CFR part 11, and practical application of CSV industry standard best practices. Possess exceptional communication, analytical and problem-solving skills along with team-based management style coupled with the zeal.

Overview

10
years of professional experience

Work History

Infosys Limited

Senior associate Consultant
10.2022 - Current

Job overview

  • Company Overview: Client: Teva Digital Health (DH)/ Novartis
  • Working on Medical Devices (SaMD), mainly responsible for Preparation and Review of Validation Document deliverables Like DDP (Design Development Plan), RMP (Risk Management Plan), Design Trace matrix (DTM), Verification Documents like Installation Qualification, Operational Qualification and Validation Documents like UAT (User Acceptance test) / Performance Qualification (PQ), Other Deliverables like Validation plan, Validation Summary report
  • Knowledge on ISO 13485, ISO 14971 and 21 CFR 20, 21 CFR Part 11, GAMP-5
  • Client: Teva Digital Health (DH)/ Novartis

Novo Nordisk India Pvt. Ltd.

Associate Quality Assurance
01.2019 - 10.2022

Job overview

  • Responsible for overall maintenance of Quality Management system in the organization
  • Coordination for preparation of Audit plan and conduct audit at distributors warehouse and other vendor audits
  • (ISO 9001:2015 Qualified Lead Auditor)
  • Good working knowledge on Change Management, Deviations and Corrective and Preventive Actions (CAPA) investigation
  • Review of the Validation deliverables for GAMP categories like IQ, OQ, MQ, PQ Scripts, Validation Plan, Validation Summary Report, Environment Release memos/Validation Certificate
  • Performing Root Cause analysis on process deviations/ Quality issues, Document Management, Deviation Management and Change Control Management

Mylan Laboratories Ltd.

Officer
06.2017 - 01.2019

Job overview

  • Responsible for IPQA activities in Compression, granulation and packaging in pharma manufacturing

Macleods pharmaceuticals Ltd, India

Jr. Officer
03.2015 - 06.2017

Job overview

  • Responsible for IPQA activities in Compression, granulation and packaging in pharma manufacturing

Education

Pune University
Maharashtra

M. Pharmacy from Pharmaceutics
06.2015

University Overview

  • First class with distinction
  • GPA: 76.5%

S.R.T.M. University
Nanded, Maharashtra

B. Pharmacy
04.2013

University Overview

  • First Class with Distinction
  • GPA: 77%

Maharashtra Board
Latur

HSC
06.2009

University Overview

GPA: 84.00%

Maharashtra Board
Latur

SSC
06.2007

University Overview

GPA: 82.00%

Skills

  • Quality Assurance
  • Commissioning / Qualification of Equipment’s
  • JIRA
  • HP-ALM
  • IT -CSV Validation (E-VLMS, Trackwise)
  • E-Compliance and Quality Assurance
  • Good Manufacturing Practice (GMP)
  • Quality Assurance (Tablet Formulations)
  • Good Documentation Practices

Accomplishments

  • Qualified GPAT conducted by AICTE in 2013
  • ISO 9001:2015 Qualified Lead Auditor
  • Infosys certified Computer system validation practitioner

Locationpreference - Locations

  • India, Pan India
  • Global

Personal Information

  • Date of Birth: 11/22/91
  • Marital Status: Married

Languages

  • English
  • Hindi
  • Marathi

Hobbies and Interests

  • Reading
  • Listening music
  • Podcasts

Disclaimer

I, Suraj Bhagwatrao Bidwai hereby declare that the above-furnished information is true to the best of my knowledge.

Timeline

Senior associate Consultant

Infosys Limited
10.2022 - Current

Associate Quality Assurance

Novo Nordisk India Pvt. Ltd.
01.2019 - 10.2022

Officer

Mylan Laboratories Ltd.
06.2017 - 01.2019

Jr. Officer

Macleods pharmaceuticals Ltd, India
03.2015 - 06.2017

Pune University

M. Pharmacy from Pharmaceutics

S.R.T.M. University

B. Pharmacy

Maharashtra Board

HSC

Maharashtra Board

SSC

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Suraj Bhagwatrao Bidwai