Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic
SIDDHARTH WAGHMARE

SIDDHARTH WAGHMARE

CSV Specialist
Pune

Summary

Effective Team leader and Computerized system validation specialist with 16+ year experience in quality control department in Pharmaceutical industry.

Overview

17
17
years of professional experience
6
6
years of post-secondary education
1
1
Certification
1
1
Language

Work History

Asst. Manager-IT

Emcure Pharmaceuticals Ltd.
Pune
09.2022 - Current
  • Demonstrated leadership skills in managing projects from concept to completion.
  • Assessment and managing CSV activities for QC and Manufacturing applications
  • Leading and team coordination for CSV activities at three sites
  • Review and approval of project deliverables such as URS, FRS, Project Validation plan, Risk Rating Assessment (functional), ERES Assessment, 3rd party assessment, Requirement traceability matrix and validation summary report.

Asst. Manager - Quality Control

Emcure pharmaceuticals Ltd
Pune
05.2014 - 09.2022
  • Supervised day-to-day operations to meet performance and quality.
  • Completed regular inventory counts to verify stock levels, address discrepancies, and forecast future needs.
  • Coordination with vendors of respective instruments, Prepare URS and other CSV deliverables.
  • Team management and analytical review in Raw Material, Stability, Working standard and GLP section.
  • Investigation of laboratory events, OOS/OOT, deviation, OOC etc.
  • Working standard management.

Quality Control Executive

Lupin Limited
Verna-Goa
08.2011 - 04.2014
  • Review of stability study data, certificate of analysis and QC records.
  • Review of electronic data and audit trails.
  • Performed root cause analysis to identify and resolve quality issues and defects.
  • Analysis of stability samples.

QC Officer

Glenmark Pharmaceuticals Limited
Verna- Goa
09.2008 - 06.2011
  • Analysis of Stability samples and verify quality.
  • Kept equipment operating and in good condition by performing quality checks and calling in for repairs when needed.
  • Reported problems and concerns to management.

QC Chemist

Zydus Cadila
Ankleshwar-Gujarat
10.2007 - 09.2008
  • Analysis of Raw Material and stability sample analysis
  • Chemical testing of Raw Material samples.
  • Prepared and standardized test solutions and reagents to enable successful testing completion.

QC Chemist

IPCA Laboratories
Aurangabad - Maharashtra
09.2006 - 10.2007
  • Performed physical testing and chemical analysis of raw chemical materials and finished products.
  • Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.

Education

Master of Science - Analytical Chemistry

Science College, Swami Ramanand Marathwada University
Nanded, Maharashtra.
06.2003 - 06.2005

Bachelor of Science - Chemistry, Botany, Industrial Microbiology

Science College, Swami Ramanand Marathwada University
Nanded, Maharashtra
06.1999 - 06.2003

Skills

Computerized system validation (CSV)

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Accomplishments

Coordinated many audits, including those by the USFDA, MHRA, WHO, and ANVISHA, successfully.

Certification

Certified six sigma green belt

Timeline

Certified six sigma green belt

07-2023

Asst. Manager-IT

Emcure Pharmaceuticals Ltd.
09.2022 - Current

Asst. Manager - Quality Control

Emcure pharmaceuticals Ltd
05.2014 - 09.2022

Quality Control Executive

Lupin Limited
08.2011 - 04.2014

QC Officer

Glenmark Pharmaceuticals Limited
09.2008 - 06.2011

QC Chemist

Zydus Cadila
10.2007 - 09.2008

QC Chemist

IPCA Laboratories
09.2006 - 10.2007

Master of Science - Analytical Chemistry

Science College, Swami Ramanand Marathwada University
06.2003 - 06.2005

Bachelor of Science - Chemistry, Botany, Industrial Microbiology

Science College, Swami Ramanand Marathwada University
06.1999 - 06.2003

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SIDDHARTH WAGHMARECSV Specialist