Asim Kumar Roy

Senior Quality Assurance leader with 16+ years of experience in sterile pharmaceutical and biologics manufacturing, specializing in facility start-up, technology transfer, validation lifecycle management, and regulatory compliance. Currently leading QA oversight for sterile insulin manufacturing and contract production for Novo Nordisk at Eskayef Pharmaceuticals Limited, including validation, aseptic processing, and quality systems management.

Extensive expertise in Validation Master Plan implementation, equipment and utility qualification (IQ/OQ/PQ), process validation (PPQ), media fills, and contamination control strategies for sterile manufacturing facilities. Proven experience supporting brownfield expansion projects, QC laboratory setup, and technology transfer of biologics products while ensuring full compliance with global regulatory standards.

Successfully supported and led multiple international regulatory inspections, including US FDA, ANVISA Brazil, and MHRA, maintaining compliance with cGMP, EU GMP, and global client quality requirements. Strong leadership experience in building high-performing QA teams, strengthening Quality Management Systems (QMS), and driving continuous improvement through CAPA, risk management, and inspection readiness programs.

Recognized for stakeholder management, cross-functional leadership, and regulatory inspection preparedness, with a strong commitment to quality culture, operational excellence, and global compliance in biopharmaceutical manufacturing.

As an Auditee,
• Novo Nordisk Global Audits (6 successful audits)

• US-FDA Inspections (Sterile facility),
• ANVISA Brazil (Sterile facility),
• EU GMP (Sterile facility)
• MHRA Audits (Solid facility),
• Other Regulatory Audits (Uganda, Kenya, Save the Children, UNICEF).

As Lead Auditor
• Led vendor audits for sterile raw materials, packaging materials, calibration labs, and sterile equipment at facilities in India and China.

• American Society for Quality (ASQ)
• International Society for Pharmaceutical Engineering (ISPE)
• Parenteral Drug Association (PDA)
• Society of Quality Assurance (SQA)
• ECA - Interest Group

• Successfully supported and managed multiple global regulatory inspections, including US FDA, ANVISA Brazil, and global quality audits conducted by Novo Nordisk, ensuring strong compliance outcomes and effective resolution of audit observations.
• Led the technology transfer of Novo Nordisk Penfill insulin products to Eskayef Pharmaceuticals Limited, ensuring seamless integration of manufacturing processes, validation requirements, and regulatory compliance within the sterile manufacturing facility.
• Demonstrated strong expertise in EU GMP, US FDA, WHO GMP, and PIC/S regulatory frameworks, maintaining high standards of product quality, data integrity, and inspection readiness across sterile manufacturing operations.
• Directed validation lifecycle activities for sterile manufacturing systems, including aseptic process validation, cleaning validation, equipment qualification, and utility system validation, ensuring sustained compliance with global regulatory expectations.
• Strengthened the Quality Management System (QMS) by improving deviation management, CAPA effectiveness, and documentation control systems, significantly enhancing audit readiness and operational compliance across the sterile manufacturing site.
• Spearheaded validation activities for aseptic processes, cleaning, equipment, and utility systems in a sterile environment, ensuring ongoing regulatory compliance.
• Implemented a comprehensive Quality Management System (QMS) aligned with EU GMP and FDA guidelines, significantly enhancing documentation accuracy, deviation tracking, and audit readiness across the sterile production facility.

• Europe (Denmark, Sweden, France)
• Asia (India, China, Nepal, Malaysia, Thailand)

· Systematic Problem Solving (A3 Investigation), Novo Nordisk, Denmark, 2014 (1 week) & refresh training through online (2021)

· Penfill Tech Transfer Training, Novo Nordisk, Tianjin, 2018 (4 weeks))

· Calibration & HVAC Training, Novo Nordisk Specialist UTho (2017 & 2022)

· OOS Investigation Training, Novo Nordisk Expert (2019)

· Environmental Monitoring, Smoke Study and aseptic behavior training by Novo Nordisk

· Participate in Metrology training by NN specialist Jeanett (2018)

· Participated in training regarding MHRA audit conducted by Mr. Rob Walker

· Microbiology & Sterility Assurance, Radha Tirumalai (USP Approved Instructor)

· Training on GMP Auditor Qualification by Vasundhara (Vasu) Rama Iyengar

· PDE Calculation for Cleaning Validation, Adam Woolley (European Registered Toxicologist)

· Pharmacovigilance training by Mr. Mukund Jha and Dr. (Ms.) Manoj

· Participate in CSV training certification by Gireesh T. (Consultant and Trainer)