Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Sandip Mantri

Sandip Mantri

SENIOR QUALITY CONTROL & REGULATORY COMPLIANCE MANAGER
Mumbai

Summary

Highly accomplished Quality Control & Assurance Professional with 30+ years of experience in the Indian pharmaceutical industry. Led the design, qualification, and regulatory approval of a state-of-the-art small animal breeding & experimental facility for biological testing. Ensured regulatory compliance with CDSCO, FDA Maharashtra, and CPCSEA guidelines. Expertise in microbiology, sterility testing, analytical method validation, and Indian regulatory audits. Adept in process optimization, business strategy, and quality management systems. Looking for senior leadership opportunities in Indian pharmaceutical companies.

Overview

32
32
years of professional experience
2
2
years of post-secondary education
4
4
Certifications
3
3
Languages

Work History

Independent Business Venture
09.2021 - Current
  • Managed a pharmaceutical business, overseeing operations and strategic planning
  • Applied Power BI analytics to optimize processes and data management
  • Studied Business Philosophy for improved leadership and management strategies

Bharat Serums & Vaccines Ltd.
04.2002 - 09.2021
  • Designed, qualified, and secured regulatory approvals for a ₹25 Crore small animal testing facility
  • Managed microbiological, biological, chemical, and pharmacological testing (Sterility, BET, MLT, Microassay, Bioassay, Pyrogen, Abnormal Toxicity, etc.)
  • Conducted regulatory audits with CDSCO, WHO-GMP, FDA Maharashtra, and CPCSEA
  • Provided GLP and EHS training to ensure compliance
  • Led OOS laboratory investigations and CAPA implementation

Fresenius Kabi India Ltd.
09.1997 - 04.2002
  • Conducted process validation, equipment calibration, and ISO 9002 documentation
  • Led WHO-GMP certification efforts by coordinating regulatory compliance strategies

Famy Care Ltd.
07.1993 - 08.1997
  • Ensured compliance with ISO 9002 for medical disposable devices
  • Conducted raw material sampling and microbiological testing

Education

M.Sc. - Microbiology

North Maharashtra University
01.1991 - 01.1993

Diploma in Pharma Packaging Management - undefined

IPER Institute

Diploma in Quality Control & Assurance Management - undefined

IPER Institute

Skills

  • Quality Control & Assurance (QC/QA)
  • GLP
  • cGMP
  • WHO-GMP Compliance
  • ISO 9000
  • Analytical & Biological Method Validation
  • Sterility
  • Microbiological
  • Pyrogen
  • Abnormal Toxicity
  • Bioassay Testing
  • Process Optimization
  • Risk Assessment
  • Indian Regulatory Compliance (CDSCO, FDA Maharashtra, CPCSEA)
  • Root Cause Analysis
  • CAPA (Corrective and Preventive Action) Implementation
  • Statistical Process Control
  • FMEA (Failure Mode and Effects Analysis)
  • Business Strategy
  • Leadership
  • Project Management
  • Budgeting
  • Cleanroom Validation
  • Stability Studies

Certification

WHO Prequalification of Snake Antivenom Immunoglobulins – Bangkok, Thailand Conference attended.

Timeline

Independent Business Venture
09.2021 - Current

WHO Prequalification of Snake Antivenom Immunoglobulins – Bangkok, Thailand Conference attended.

11-2019

GLP Training for Study Directors & QA Personnel – NGCMA, New Delhi

10-2018

ISO 9001, GMP, GLP, Lean Management, Kaizen, Fire Safety Training

10-2015

Sterilization Technology - BARC, Cold Chain Logistics - DHL

07-2013

Bharat Serums & Vaccines Ltd.
04.2002 - 09.2021

Fresenius Kabi India Ltd.
09.1997 - 04.2002

Famy Care Ltd.
07.1993 - 08.1997

M.Sc. - Microbiology

North Maharashtra University
01.1991 - 01.1993

Diploma in Pharma Packaging Management - undefined

IPER Institute

Diploma in Quality Control & Assurance Management - undefined

IPER Institute

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Sandip MantriSENIOR QUALITY CONTROL & REGULATORY COMPLIANCE MANAGER