Open to opportunities

Nikhil Chavan

@nikhilchavan8977

Message

Senior QA and validation professional driving GMP compliance, CQV, and process excellence in biopharma.

India

Message

What I'm looking for

I’m looking for a regulated biopharma role where I can lead CQV, validation (CSV/GAMP5), and GMP quality systems—driving operational excellence, audit readiness, and process optimization through cross-functional execution and continuous improvement.

I’m a biopharmaceutical manufacturing and operational excellence professional with 8+ years of experience across GMP manufacturing, quality systems, validation, process optimization, and technology transfer within regulated biologics and biosimilar environments.

I lead cross-functional initiatives in commissioning & qualification (CQV), process validation, manufacturing scale-up, Lean improvement, and audit readiness—strengthening compliance systems, reducing inefficiencies, and enabling commercialization programs. I’ve delivered qualification and compliance execution for pharmaceutical projects of about ₹200M across geographies, supported regulatory inspection readiness for US FDA, EMA, and PMDA environments, and executed CSV activities aligned with GAMP5 and data integrity requirements.

Experience

Work history, roles, and key accomplishments

Current

Senior QA Engineer

Current

DDE Bioengineering Pvt. Ltd.

Jan 2025 - Present (1 year 6 months)

Leading qualification and compliance activities for pharmaceutical/biopharmaceutical projects across client locations. Manages equipment qualification (URS, DQ, IQ/OQ/PQ), supports CSV aligned with GAMP5/GMP, and coordinates cross-functional teams and client stakeholders.

URS DQ IQ OQ PQ Process Validation GMP CSV Data Integrity Deviation Management CAPA Change Control Stakeholder Management

Process R&D Scientist

Dr. Reddy’s Laboratories

Dec 2021 - May 2024 (2 years 5 months)

Led process development and scale-up for complex biosimilar APIs, supporting technology transfer and commercialization. Executed process validation batches, equipment qualification lifecycle activities, and CSV for GMP laboratory systems; optimized downstream purification workflows using chromatography.

Process Development Scaling Process Validation Technology Transfer URS Performance Evaluation CSV GxP Downstream Purification Process Optimization

Jr. Executive

Wockhardt Biotech Park

May 2021 - Dec 2021 (7 months)

Supported GMP manufacturing operations for insulin products at 10KL commercial scale. Strengthened batch documentation through deviations/CAPA/change control, operated purification and lyophilization activities, and used PharmaSuite MES for electronic batch execution and compliance.

GMP Compliance Insulin Insulin Glargine Deviations CAPA Batch Documentation Change Control Lyophilization PharmaSuite Audit Readiness

Executive

Biocon Biologics India Limited

Sep 2017 - Apr 2021 (3 years 7 months)

Supported large-scale GMP manufacturing operations for insulin products at 30+KL production scale. Managed shop-floor compliance through deviations, CAPA, batch record review, and change control; supported regulatory inspection readiness and used MES tools for electronic batch execution and quality documentation.