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Divya Chouhan

@divyachouhan1

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I lead GMP quality systems, CAPA, audit readiness, and regulatory compliance.

India

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What I'm looking for

I'm seeking a Quality Systems or Compliance Manager role where I can drive GMP compliance, audit readiness, CAPA effectiveness, and quality governance for a manufacturing site in the Gurugram–Bhiwadi region.

I've strengthened quality management systems, documentation, and audit readiness across regulated manufacturing sites in India, the USA, and Canada for more than 14 years.

At Roquette Canada, I led QC operations for the world's largest pea protein manufacturing facility, supporting plant-based proteins, nutrition ingredients, pharmaceutical excipients, and specialty ingredients. I partnered across Production, R&D, Regulatory Affairs, Supply Chain, and Commercial teams on product development, compliance, and operational consistency.

I led CAPA, deviation, OOS/OOT, complaint, and risk-assessment investigations, while developing testing strategies and documentation for FDA and CFIA submissions. I also supported customer, third-party, and regulatory audits through stronger procedures, documentation, training, and technical responses.

Previously at Roquette America, I led analytical, microbiology, and refinery laboratory functions supporting pharmaceutical excipients and specialty carbohydrates. I build audit-ready laboratory cultures through method validation, data integrity, process improvement, team development, and practical quality governance.

Experience

Work history, roles, and key accomplishments

Plant QC Head / QC Manager

Roquette Canada Inc.

May 2023 - Mar 2026 (2 years 10 months)

Led all QC operations for the world's largest pea protein manufacturing facility, managing multiple labs and ensuring GMP, regulatory, and customer compliance. Served as key quality partner to cross-functional teams and led regulatory dossier support for FDA and CFIA submissions.

Quality Management Systems GMP CAPA Root Cause Analysis Audit Readiness Regulatory Submissions method validation Data Integrity Risk Assessment Training SOP Development

Analytical Lab Head / QC Lab Leader

Roquette America, Inc.

Sep 2014 - Oct 2019 (5 years 1 month)

Managed the site's central analytical laboratory, expanding from a team of 5 analysts to oversight of three laboratory functions. Led a multidisciplinary team, directed investigations, CAPA implementation, and data integrity initiatives.

Laboratory management CAPA Root Cause Analysis Data Integrity Audit Readiness Team Leadership Analytical Chemistry

Microbiological Specialist

Roquette America, Inc.

Dec 2011 - Sep 2014 (2 years 9 months)

Developed, validated, and implemented microbiological methods in accordance with USP, BAM, European Pharmacopeia, and ISO requirements. Led investigations, CAPA activities, and root cause analyses, and supported GMP, FDA, customer, and third-party audits.

Microbiology method validation USP BAM ISO CAPA Root Cause Analysis Audit Support GMP FDA

Associate Scientist

Molecular Express

Dec 2010 - Nov 2011 (11 months)

Supported biotechnology research, analytical testing, experimental design, and technical documentation.

Biotechnology Research Bio Analytical Testing Experimental Design Technical Documentation

Laboratory Technician

Pioneer Hi-Bred

Mar 2010 - Nov 2010 (8 months)

Conducted laboratory testing and supported analytical operations in an agricultural biotechnology environment.

Laboratory Testing Analytical Operations Agricultural Biotechnology

Lecturer, Pharmaceutical & Medicinal Chemistry

Devi Ahilya College of Pharmacy

Jan 2007 - Dec 2008 (1 year 11 months)

Delivered undergraduate instruction in Pharmaceutical Chemistry and Medicinal Chemistry, and provided practical laboratory training and student mentoring.

Teaching Medicinal Chemistry Laboratory Training Mentor