Hi, I’m
Chetan Dave
Head - Quality
Bharuch
Summary
Dynamic Quality Leader with over 18 years of experience in Quality Assurance, R&D, and Regulatory Compliance (USFDA, MHRA, TGA, ANVISA, ISO 9001 , ISO 22000). Proven track record in spearheading lean operations, driving Six Sigma initiatives, and successfully managing 10+ major international audits with zero major observations. Expert in product life-cycle management and complex analytical troubleshooting for Pharmaceuticals, Nutraceuticals and Chemicals
Overview
16
years of professional experience
1
Language
Work History
LanXess India Pvt. Limited
Head – QA & QC
09.2025 - Current
Job overview
- QA Leadership: Drive Quality Culture Initiatives to evolve Quality Consistent Processes and processes to avoid all types of wastes and rejections
- QC Reliability : Lead the QC team to the reliability level
- Project Support : Drive New Product Development and also developed analytical method validation for new product launches.
- Budget Compliance : Inculcate cost considerations in QC
Abbott Healthcare Pvt. Ltd.
Senior Manager – Quality Labs Operations – Analytical , Microbiology and Incoming QA Lab
04.2016 - 09.2025
Job overview
- Manager – Validations & Quality Excellence |Mar 2023 to Jun 2024
- Manager – Quality Excellence |Jun 2020 to Mar 2023
- Assistant Manager – Analytical Lab Operations |Nov 2018 to Jun 2020
- Assistant Manager – Validations |Sep 2017 to Nov 2018
- Assistant Manager – Incoming Quality Labs |Apr 2016 to Sep 2017
- Six Sigma Leadership: Drive lean excellence projects using DMAIC to optimize plant KPIs and operational cost-savings of $240 M.
- Audit Readiness: Lead the QA Lab team in regulatory preparations; successfully maintained compliance across non-routine projects.
- Technology Transfer: Spearhead scale-up operations and Six New analytical method Transfers for Six new product launches.
- Validation Excellence : Successfully handled 3 major Shutdowns with due compliance and Right First Time status
- System Validation: Independently executed installation/validation for ICP MS (MassHunter), Empower 3, LabX, and Win Lab
- Strategic Planning: Core member for Financial/Non-financial budgeting and Functional KPI preparation.
Amanta Healthcare Pvt. Ltd.
Asst. Manager – QC Compliance
12.2010 - 04.2016
Job overview
- Audit Success: Successfully cleared USFDA, TGA, MHRA, and MCC audits with zero observations during OOS & OOT reviews.
- Compliance Infrastructure: Managed 21 CFR compliance for analytical instruments and led data integrity/reliability projects.
- Team Leadership: Supervised total GMP compliance for a QC function of 52 personnel.
- Vendor Management : Developed and managed Vendor Management from Scratch to 100% Compliance
Claris Lifesciences
Group Leader – ADL
05.2010 - 12.2010
Job overview
- Developed and validated RS methods for Zoledronic Acid and Bupivacaine Injections for US/EU markets within short span of 3 months.
Education
Bhavnagar University
Ph.D. from Chemistry
Bhavnagar University
M.Sc. from Analytical Chemistry
University Overview
GPA: Gold Medallist
Bhavnagar University
B.Sc. from Chemistry
Skills
Regulatory Mastery: USFDA, UK-MHRA, TGA, ANVISA, WHO-GMP, ISO 9001, FSSC 22000, EFFCI GMP
Quality Operations: QMS, Data Integrity (ALCOA), Risk Management (ICH Q9), Method Validation
Strategic Leadership: Six Sigma (DMAIC), Lean Manufacturing, Resource Planning, Budgeting
Technical Proficiency: Empower 3, LIMS, SAP, eCTD, MassHunter
SIGNATURE ACHIEVEMENTS
- Global Recognition: Awarded by Global DVP-QA for "Remarkable Contribution to Quality Functions."
- Operational Efficiency: Reduced Arsenic levels from Percentage to PPM at Hindalco Industries via literature-based method development.
- Zero-Defect Record: Managed unannounced FDA audits (May 2015) with zero observations.
Timeline
Head – QA & QC
LanXess India Pvt. Limited
09.2025 - Current
Senior Manager – Quality Labs Operations – Analytical , Microbiology and Incoming QA Lab
Abbott Healthcare Pvt. Ltd.
04.2016 - 09.2025
Asst. Manager – QC Compliance
Amanta Healthcare Pvt. Ltd.
12.2010 - 04.2016
Group Leader – ADL
Claris Lifesciences
05.2010 - 12.2010
Bhavnagar University
Ph.D. from Chemistry
Bhavnagar University
M.Sc. from Analytical Chemistry
Bhavnagar University
B.Sc. from Chemistry