Summary
Overview
Work History
Education
Skills
Expertise In Software Handling
Certification
National Awards And Recognition
Personal Information
Languages
Extracurricular Activities
Hobbies and Interests
Projects
Timeline
Generic
RAMANUJ SEN CHOWDHURY

RAMANUJ SEN CHOWDHURY

Chandigarh

Summary

As a Research Manager in Sun Pharmaceutical Industries Ltd under Global Data Integrity Cell (ODR), I am an accomplished professional with expertise in Internal Audit Management (CQA), Data Integrity Audit, Audit Trial Management, and Gap Assessment. I also excel in simplifying and automating Quality Systems for improved business outcomes. My strong communication and interpersonal skills have enabled me to effectively network, collaborate, and maintain positive partnerships with Cross Functional Team (CFT) members on a global scale. Furthermore, I am proficient in managing diverse departments, professionals, and programs through a comprehensive understanding of compliance in the Analytical QA domain.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Manager (Global DI Cell)

Sun Pharmaceutical Industries Ltd
Mohali
03.2022 - Current
  • Specially Expertise & currently working in CONCENT DECEREE Remediation
  • Performing site quality DI audit and expert handling of Disclosure Investigations
  • Identification of Systemic Gaps and Data Integrity Lapses and further working together with site stakeholders for its resolution
  • In depth review of executed Batch records which are approved by QA, CQA and ensure the DI Compliance accuracy
  • Auditing Completeness and Integrity of data meant for regulatory submission to USFDA
  • In depth review of all QMS events of analytical and manufacturing reports
  • Final review and gap assessments of Nitrosamine's and Elemental Impurities Risk Assessment.
  • Preparation of Audit Trend Reports and continuous development of audit checklist as per current Regulatory audit observations
  • Imparted Training to Stakeholders based on internal and regulatory audit observations
  • Monthly Auditing in QC Lab.

Sr.Executive

Strides Pharma Science LTD
Bangalore
09.2019 - 03.2022
  • Conducted risk-based (onsite & virtual) internal audits across 03 manufacturing sites, leading to continuously increase audit accuracy.
  • Prepared an annual internal audit planner using a risk-based approach, ensuring comprehensive coverage of audit areas.
  • Executed scheduled and unscheduled audits across all sites to assess compliance and identify potential areas for improvement.
  • Identified systemic gaps within the existing processes and worked collaboratively with sites to develop and implement effective resolution strategies.
  • Identified and addressed data integrity lapses, leading to a 40% improvement in data accuracy.
  • Conducted in-depth audit trial reviews to ensure adherence to regulatory standards and best practices.
  • Performed GMP trend, warning letter, and 483 assessments to evaluate site compliance and proactively mitigate potential issues.
  • Implemented compliance actions for systemic gaps through the global Corrective and Preventive Action (CAPA) system, driving effective reduction in repeat audit observations.
  • Provided GxP training at sites to enhance team's understanding of compliance requirements and best practices.
  • Conducted risk assessments on Nitrosamine and Elemental impurities for the US, MHRA, and TGA markets, ensuring alignment with regulatory guidelines and standards.
  • Auditing expertise in ERDS (QC) (Electronic Records Document Management System), facilitating efficient management.

Senior Executive - QC

Aurobindo Pharma LTD (Unit-7)
Hyderabad
11.2015 - 09.2019
  • Timely handling of departmental deviations
  • Execution of CAPA and effectiveness checks
  • Assisting CQA team in audit readiness
  • Proficient in preparing OOS and OOT investigations reports
  • Expert analytical skills in stability sample testing.

Executive

Torrent Pharmaceuticals LTD
Sikkim
04.2013 - 11.2015
  • Demonstrated strong analytical skills finished products and stability sample testing
  • Conducted analysis of packaging material sample testing
  • Proficient in Raw materials sampling and documentation, ensuring accuracy and compliance
  • Managed a sampling team of 06 persons, leading to efficient and accurate sampling processes.

Trainee

Wockhardt. LTD
Himachal Pradesh (Baddi)
06.2012 - 03.2013
  • Demonstrated expertise in raw material and packing material sampling and documentation
  • Conducted rigorous testing of raw material and packing material to ensure quality standards are met
  • Supported the QC team to ensure audit readiness at all times.

Education

M.Pharma - Pharmacy - Pharmaceutics

West Bengal University Of Technology
West Bengal
05-2012

B.Pharma - Pharmacy - Pharmacy Technology

West Bengal University Of Technology
West Bengal
01.2010

Skills

  • Audit Trial Management
  • Audit Compliance
  • Audit Management
  • Audit Trend Report
  • Risk Assessment
  • Performing site quality DI audit and expert handling of Disclosure Investigations
  • Identification of Systemic Gaps
  • Gap Assessment
  • Communication Skills
  • QMS System
  • War Room Management
  • CAPA
  • Disclosure Investigation
  • Leadership Quality
  • Team Work
  • Time Management
  • Problem Solving
  • Decision Making
  • Data Integrity Auditing
  • Expert In 21 CFR

Expertise In Software Handling

  • Chromatography & Standalone Software's
  • Empower 3, Chromeleon 7.2.10, LIMS Lab Ware 7.0 along with Electronic Data Management System, Caliber LIMS 3.2.1, Track Wise, Tiamo 2.5, Lab X, IR Solutions

Certification

  • FDA Inspections Of Outsourcing Facilities (USFDA)
  • Quality Management Maturity Workshop (USFDA)
  • Office Of Study Integrity And Surveillance Workshop (USFDA)
  • USFDA Workshop On" What To Expect After An Inspection 483s, Responses And Beyond".
  • Electronic Systems, Electronic Records And Electronic Signatures Webinar (USFDA).
  • How To Make Your Quality Management System 100% Paperless (Qualistery).
  • Understanding FDA Inspection And Data Webinar (USFDA).
  • Joint USFDA Health Canada ICH Public Meeting (USFDA).
  • Foundations Of GMP: Data Integrity And Computer System Validation (USP).
  • Nitrosamine Impurities In Drugs: What Health Care Professionals Need To Know ( USFDA).
  • Foundations Of GMP: Quality Risk Management (USP).
  • Foundations Of GMP: Auditing ( USP, USAID).
  • How To Be Constantly Audit Ready (Qualistery).
  • Work Smarter, Not Harder: Time Management for Personal & Professional Productivity (University Of California).
  • Effective Problem-Solving and Decision-Making Coursera, University of California, Davis (University Of California).
  • Webinar: Explore The GAMP Data Integrity By Design Guide ( ISPE).
  • High Performance Collaboration: Leadership, Teamwork, and Negotiation ( North Western University).
  • Organizational Skills ( Career Development College London).
  • AI In Healthcare ( Great Learning Academy).

National Awards And Recognition

  • On 2012 Got 3rd Prize In The National Seminar of Recent Research Trends In Herbal Medicines.
  • On 2011 Got Best Research Paper Award In National Seminar By Forum Of Scientists Engineers And Technologists (FOSET) With Scholarship For One Time.
  • Best Safety Award Received on the Year Of 2012 (Wockhardt LTD, Baddi)

Personal Information

  • Date of Birth: 11/11/1987
  • Marital Status: Married

Languages

  • English
  • Hindi
  • Bengali

Extracurricular Activities

Cricket & Singing

Hobbies and Interests

  • Learning AI on DI
  • Space Research & Time Travel Theory
  • Study Regulatory Observations

Projects

Risk Assessment On Nitrosamine & Elemental Impurities, 04 Months, Executed multiple projects for regulatory markets such as USFDA, MHRA, and TGA.

Timeline

Manager (Global DI Cell)

Sun Pharmaceutical Industries Ltd
03.2022 - Current

Sr.Executive

Strides Pharma Science LTD
09.2019 - 03.2022

Senior Executive - QC

Aurobindo Pharma LTD (Unit-7)
11.2015 - 09.2019

Executive

Torrent Pharmaceuticals LTD
04.2013 - 11.2015

Trainee

Wockhardt. LTD
06.2012 - 03.2013

M.Pharma - Pharmacy - Pharmaceutics

West Bengal University Of Technology

B.Pharma - Pharmacy - Pharmacy Technology

West Bengal University Of Technology
RAMANUJ SEN CHOWDHURY