100 % Placement Assistance
❖ Name of Mentor : Kumar Kurle
❖ Qualification and certification
• Masters in Microbiology with strong subjective background of Chemistry, Biochemistry, biotechnology, molecular biology and Microbiology. And
certified GMP professional and six sigma black belt form American society of quality (ASQ)
• 22 years of experience in pharmaceutical and biopharmaceutical industries like Cipla, Wockhardt, Emcure, Piramal and Dr. Reddy’s laboratories. Pharmaceutical quality consultant and a passionate trainer.
• Problem solving, Training, mentoring, Risk assessment, Six Sigma
❖ Experience and Expertise
• Rich experience in quality systems implementation, regulatory audits and compliance, technology transfer, process development & scale up of
pharmaceuticals and bio-pharmaceuticals APIs and finished products. He is adept in Equipment validation, computer system validation, Process
and cleaning validation, specifications and Analytical Method Development and validation involving Chemistry, Biochemistry, Molecular Biology and Microbiology.
• Expertise includes management of diverse business processes with implementation of latest Quality Management Tools; preparing the Quality
Assurance Plans, handling customer complaints, deviations, Change and CAPA management.
• Deep understanding of pharmaceutical manufacturing and quality control processes including API synthesis, fermentation, protein purification,
sterile and non-sterile fill finish operations.
• Deep understanding, interpretation and implementation skills of national and international regulatory requirements and guidelines.
Training and Services offered
1) GMP Training for graduates and entry level candidates in pharma industries
2) Advanced GMP training for experienced pharma professionals
o Improving documentation skill
o Deviation investigation and report writing
o CAPA management
o Process validation and Continuous process performance verification
o Analytical method validation and Continuous method performance verification
o Risk management
o Change management
o Equipment validation and life cycle management
o Use of statistical tools in trending and conducting product reviews
o Design and maintenance of quality system