Biography

About the Instructor

Nilesh Ghute is a Senior Pharmaceutical Quality Management Professional with extensive experience in quality assurance, regulatory affairs, vendor management, and business development across global pharmaceutical operations. With expertise spanning APIs, CDMO, specialty chemicals, and CQA operations, Nilesh combines technical depth with strategic insight, ensuring compliance with ICH, FDA, and global regulatory standards.

Throughout his career, Nilesh has led end-to-end quality management initiatives, including audits (USFDA, PMDA, ISO), change control, CAPA, OOS/OOT investigations, and continuous improvement projects. He has a proven ability to manage cross-functional teams, drive operational excellence, and implement robust quality systems, making his teaching highly practical for learners aiming to excel in quality assurance, regulatory compliance, and pharmaceutical manufacturing.

Education

• MBA in Business Analytics, Pune University, India (2024)

• M.Sc. in Organic Chemistry, Pune University, India (2018)

• B.Sc. in Chemistry, Pune University, India (2016)

• HSC, Maharashtra State Board, India (2011)

• SSC, Maharashtra State Board, India (2009)

Professional Experience

• Executive – Quality Assurance & Regulatory, Hikal Ltd, Pune, India (2024 – Present)

• Sr. Officer – Quality Assurance, Lupin Ltd, Mumbai, India (2024)

• Chemist – Quality Assurance, Honour Lab Ltd, Pune, India (2021 – 2024)

• Chemist – Quality Assurance, Green Joules Pvt. Ltd., Pune, India (2019 – 2021)

Areas of Expertise

• Pharmaceutical Quality Management Systems (QMS)

• Regulatory Compliance & RA Documentation (ICH, FDA, cGMP)

• Vendor Development & Qualification for APIs and Contract Manufacturing

• Quality Audits (Internal, USFDA, PMDA, ISO)

• Change Control, CAPA, OOS/OOT, and Risk Assessment

• Data Integrity (ALCOA+), Documentation & SOP Management

• Project Management & Process Improvement

• Team Leadership, Training & Cross-Functional Collaboration

• Business Development in Pharmaceutical Operations

Academic & Industry Contributions

• Led quality management projects, audits, and vendor qualification in pharmaceutical operations.

• Reviewed and approved critical documents including SOPs, validation protocols, and batch records.

• Conducted staff training on cGMP, GLP, CSV, and data integrity.

• Supervised cross-functional teams to ensure compliance, efficiency, and continuous improvement.

Courses