Summary
Overview
Work History
Education
Skills
Projects Handled
Software
Languages Known
Hobbies
Disclaimer
Timeline
Generic

Mahesh Junghare

Bengaluru

Summary

Experienced Pharmaceutical Quality Assurance, Manufacturing, and Regulatory Affairs professional with 18 years of expertise in driving quality excellence within regulatory environments. Currently leading Corporate Quality Assurance initiatives at Syngene International Limited, Bengaluru, with a track record of successfully managing audits from global regulatory bodies including USFDA, MHRA, EU-GMP, TGA, MCC, WHO, and ANVISA.

Overview

18
18
years of professional experience

Work History

Deputy Manager Corporate Quality Assurance

Syngene International Limited
10.2022 - Current
  • Conduct continuous surveillance of global regulatory agencies websites and platforms (USFDA, TGA, EMA, MHRA, SAHPRA, Health Canada, WHO, ICH, PIC/s, CDSCO, etc.). Identify and track regulatory guidelines, pharmacopoeia, and non-conformance reports (such as FDA 483s and warning letters).
  • Perform comprehensive gap assessments to evaluate organizational compliance against current regulatory requirements and published non-conformance reports, ensuring Syngene’s systems align with evolving standards.
  • Lead cross-deployment of CAPAs across various operating units to drive proactive quality system improvements and prevent recurrence of non-conformities.
  • Manage and monitor the Quality Management System processes including Change Control, Deviations, OOS (Out of Specification), OOT (Out of Trend), Market Complaints, CAPA, and Validation activities to ensure compliance and continual improvement. Application- Trackwise
  • Review and support investigations related to deviations, OOS and OOT results.
  • Assist in the development and maintenance of Corporate Quality systems, policies, and procedures in compliance with national and international regulatory frameworks.
  • Coordinate and support Quality Management Review meetings to ensure ongoing quality governance and continuous improvement.
  • Ensure Any Time Audit readiness across all Syngene verticals (OSD and Injectables, API, and Biologics)
  • Lead data integrity reviews and assessments, driving corrective and preventive actions (CAPAs) and delivering targeted training to uphold compliance standards.
  • Conduct self-inspection activities, acting as the auditee to evaluate internal compliance and identify areas for improvement.
  • Coordinate and facilitate Quality Management Review (QMR) meetings to ensure effective oversight of quality systems and continuous improvement initiatives.

Assistant Manager Quality and Regulatory Assurance

Bluefish Pharmaceuticals AB
12.2016 - 10.2022
  • Collaborate with Contract Manufacturing Organizations (CMOs) to manage Change Controls, Deviations, Market Complaints, OOS (Out of Specification), Incident Investigations, APQR (Annual Product Quality Review), Batch Record Review, Retention/Customer Samples, and facility changes impacting Bluefish operations.
  • Oversee timely handling and closure of Change Controls, Deviations, Market Complaints, OOS, CAPA, Investigations, and Recalls to ensure compliance and continuous improvement.
  • Review APQR reports and investigate findings to drive corrective actions.
  • Coordinate and facilitate Quality Review Meetings to maintain quality governance and operational oversight.
  • Lead Vendor Qualification processes, Supplier Audits, and Internal Audits to ensure supplier compliance with regulatory and quality standards.
  • Ensure compliance of documents for Qualified Person (QP) to release batch in EU.
  • Impart Training to enhance awareness of Quality, GxP, and Data Integrity policies across teams.
  • Evaluate Variation Packages, Dossiers, and CEP updates from API suppliers, finished product suppliers, and Quality Control laboratories.
  • Conduct periodic GAP analyses of Bluefish dossiers with CMO documentation to ensure regulatory compliance.
  • Prepare Dossier Module 3 in eCTD format.
  • Publish dossiers in eCTD format utilizing Docubridge software.
  • Maintain product lifecycle documentation within the Regulatory Information Management System (RIMS) to ensure accurate and up-to-date regulatory records.

Senior Executive Quality Assurance

Aurobindo Pharma Ltd. Unit‐VII
08.2011 - 12.2016
  • Manage QMS activities related to Change Control, including overseeing review, approval, and successful closure of Change Controls with effectiveness monitoring using MetricStream software.
  • Manage and ensure timely closure of Deviations, Exceptions, Market Complaints, and CAPA, driving resolution and compliance.
  • Lead investigations into non-conformances and deviations to identify root causes, conduct impact analysis, and implement effective corrective and preventive actions to prevent recurrence.
  • IPQA Shift In-Charge, leaded a team of 14 members to ensure shop floor compliance with established procedures and policies.

Senior Officer Quality Assurance

Viatris Inc. (formerly Matrix Labs/Mylan Inc.)
01.2010 - 07.2011
  • Perform IPQA activities across Granulation, Compression, Coating, and Packaging areas, ensuring adherence to quality standards and regulatory compliance.
  • Conduct swab sampling and process validation sampling, and assist in the preparation of Annual Product Quality Review (APQR) reports.

Officer Quality Assurance

Microlabs Limited
07.2009 - 12.2009
  • Perform IPQA activities across Granulation, Compression, Coating, and Packaging areas, ensuring adherence to quality standards and regulatory compliance.

Officer OSD Production

BlueCross Ltd.
07.2007 - 06.2009
  • Oversee planning and execution of Tablet and Liquid Oral manufacturing activities on a daily and monthly basis to ensure smooth production operations.
  • Actively participate in day-to-day production activities, coordinating resources and workflows to meet quality and timeline objectives.

Education

B. Pharm - Pharmaceutical Sciences

Smt. Kishoritai Bhoyar College of Pharmacy
Kamptee Nagpur MS
05-2007

Diploma in Higher Secondary Education - Science

Tarkunde Dharampeth Vidyalaya
Nagpur MS
05-2002

High School Diploma -

Saint Joseph Convent
Kamptee MS
05-2000

Skills

  • Quality Management System
  • Change Control
  • Deviation
  • CAPA
  • OOS/OOT
  • APQR
  • Market Complaints
  • Investigations
  • Audit & Compliance
  • Vendor Management
  • Regulatory Surveillance
  • CAPA Cross Deployment
  • Process Validation

Projects Handled

  • Implementation of Live Line Clearance to avoid product cross contamination at Aurobindo Pharma Limited.
  • Implementation of procedure for detecting Nitrosamine impurity in API and Formulation at Syngene.
  • Implemented QMS at Bluefish .
  • Data Integrity Ambassador program at Syngene.

Software

Trackwise

Metric Stream

EDMS (Document Management))

SAP

Languages Known

English
Hindi
Marathi

Hobbies

Engaged reader with interests in philosophy, history, and global events, fostering critical thinking and a broad worldview. Passionate about traveling, which enhances cultural awareness and adaptability.

Disclaimer

I do hereby declare that the information produced above is true to best of my knowledge., Bengaluru, Mahesh Junghare, 03/02/22

Timeline

Deputy Manager Corporate Quality Assurance

Syngene International Limited
10.2022 - Current

Assistant Manager Quality and Regulatory Assurance

Bluefish Pharmaceuticals AB
12.2016 - 10.2022

Senior Executive Quality Assurance

Aurobindo Pharma Ltd. Unit‐VII
08.2011 - 12.2016

Senior Officer Quality Assurance

Viatris Inc. (formerly Matrix Labs/Mylan Inc.)
01.2010 - 07.2011

Officer Quality Assurance

Microlabs Limited
07.2009 - 12.2009

Officer OSD Production

BlueCross Ltd.
07.2007 - 06.2009

B. Pharm - Pharmaceutical Sciences

Smt. Kishoritai Bhoyar College of Pharmacy

Diploma in Higher Secondary Education - Science

Tarkunde Dharampeth Vidyalaya

High School Diploma -

Saint Joseph Convent

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