Summary
Overview
Work History
Education
Skills
Awards
Languages
Voluntary Work Experience
Affiliations
Accomplishments
Certification
Languages
Timeline
Generic
MAUTAN ROY

MAUTAN ROY

Hyderabad

Summary

Quality Operations Analyst with extensive experience at Sandoz Private Ltd and Novartis Healthcare, specializing in Quality Assurance and Lean Six Sigma methodologies. Proven ability to enhance regulatory compliance and operational efficiency through effective batch record review processes. Recipient of the Star Award for innovative contributions, demonstrating strong coordination and training capabilities that improve service delivery systems. Committed to continuous professional development in the QA field.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Analyst, Quality Operations

Sandoz Private Ltd
Hyderabad
05.2023 - Current
  • Ensured timely batch processing and product release for Kundl site, complying with regulatory standards.
  • Trained employees on Batch Record Review processes to enhance team competency.
  • Maintained Inspection Plans, CoC, and CoA to uphold compliance with requirements.
  • Assisted Kundl site team during audits to streamline batch release processes.
  • Utilized SAP and Track Wise for effective management of batch records.
  • Coordinated with customers to ensure quality and timely task completion.
  • Collaborated with cross-functional teams to maintain product quality and regulatory compliance.
  • Achieved Lean Six Sigma Yellow Belt certification, contributing to process simplification efforts.

Analyst, Quality Operations

Novartis Healthcare Private Ltd
Hyderabad
08.2022 - 04.2023
  • Streamlined processes through effective methodologies to drive continuous improvement.
  • Elevated quality and reduced costs by implementing strategic process enhancements.
  • Trained team members on service procedures, leveraging subject matter expertise.
  • Resolved data discrepancies to ensure operational accuracy across all functions.
  • Executed corrective and preventive actions during thorough root cause analysis investigations.
  • Monitored key performance indicators to evaluate progress towards established objectives.
  • Reviewed API batch documentation, and facilitated efficient batch release for the Schaftenau site.

Associate Analyst, Quality Operations

Novartis Healthcare Private Ltd
Hyderabad
08.2020 - 07.2022
  • Executed regulatory compliance checks across Latin America and external supply operations, ensuring adherence to regulations.
  • Established efficient service delivery system for COC review and upload across Nordic countries for Denmark site.
  • Identified and resolved issues within RCC LATAM process, enhancing operational effectiveness.
  • Developed tracker as Corrective and Preventive Action (CAPA) tool to improve compliance monitoring.
  • Onboarded new associates and delivered comprehensive training on Regulatory Compliance Check protocols.
  • Collaborated with QAM on regulatory compliance checks for new product launches in U.S. market.
  • Served as a Subject Matter Expert during the GCA audit, contributing significantly to the audit's success.

Education

M.PHARM - PHARMACEUTICAL ANALYSIS

UIPS, PANJAB UNIVERSITY
Chandigarh
08.2020

B. PHARM -

GNIPST, MAKAUT (WBUT)
Kolkata
08.2018

12TH GRADE -

PATHA BHAVAN
Kolkata
01.2014

10TH GRADE -

BALLYGUNGE SHIKSHA SADAN
Kolkata
01.2012

Skills

  • Quality assurance and GMP expertise
  • Root cause analysis and CAPA
  • Quality management systems
  • Audit support and inspection planning
  • Lean Six Sigma methodologies
  • Continuous improvement strategies
  • Project management
  • Batch record review
  • Regulatory compliance
  • Data analysis and KPI tracking
  • SAP proficiency
  • Employee training and development
  • Stakeholder management
  • Cross-functional collaboration
  • Communication skills
  • Leadership capabilities
  • Problem-solving techniques
  • MS Office proficiency

Awards

  • Star Award, For delivering transformative innovation and providing support for the onboarding COC Upload service in Denmark., 2021
  • Galaxy Team Award, For collaboration as a team and solve sudden challenge that has come in terms of COC Upload of Denmark., 2023
  • Star Award, For consistently going above and beyond to deliver outstanding results, demonstrating remarkable attention to detail and efficiency for the success of the ORBIT project., 2023
  • Star Award, For volunteering to take up many of QMS activities in 2023 for smooth sailing of Product Release Support team., 2023

Languages

  • Bengali, Native
  • English, Proficient (C2)
  • Hindi, Advanced (C1)

Voluntary Work Experience

Volunteered for onsite initiatives for both organizations in arranging team off sites and various events across Global Quality Services division in India., Organized GenFlex events at Novartis Healthcare Pvt. Ltd. and have also been a member of the PRIDE team at Sandoz Pvt. Ltd.

Affiliations

  • I volunteered for onsite initiatives for both organizations in arranging team off-sites and team-building activities at Novartis
  • I organized GenFlex events at Novartis Healthcare Pvt Ltd
  • I have been an active member of arranging various events across the Global Quality Services division in India
  • I have also been an active member of the PRIDE team for arranging PRIDE month events across other sites in Sandoz

Accomplishments

  • Star Award (for individuals) for delivering transformative innovation and providing support for the onboarding COC upload service in Denmark, 2021
  • Galaxy Team Award for collaboration as a team and solving sudden challenges that have come in terms of COC upload in Denmark, 2023
  • Star Award (for individuals) for consistently going above and beyond to deliver outstanding results, demonstrating remarkable attention to detail and efficiency for the success of the ORBIT project, 2023
  • Star Award (for individuals) for volunteering to take up many of the QMS activities in 2023 for the smooth sailing of the Product Release Support team

Certification

  • 'Lean Six Sigma Yellow Belt' certified under the program Lean Six Sigma Yellow Belt launched by the Sandoz Global Competency Center, Performance & Analytics team in 2024

Languages

Bengali
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1

Timeline

Analyst, Quality Operations

Sandoz Private Ltd
05.2023 - Current

Analyst, Quality Operations

Novartis Healthcare Private Ltd
08.2022 - 04.2023

Associate Analyst, Quality Operations

Novartis Healthcare Private Ltd
08.2020 - 07.2022

M.PHARM - PHARMACEUTICAL ANALYSIS

UIPS, PANJAB UNIVERSITY

B. PHARM -

GNIPST, MAKAUT (WBUT)

12TH GRADE -

PATHA BHAVAN

10TH GRADE -

BALLYGUNGE SHIKSHA SADAN

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