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Chinmayanand R Kulkarni

Associate

About Chinmayanand R Kulkarni


Chinmayanand Kulkarni is an Associate in the Compliance Practice at QualiCulture Consulting Group. He has over 16 years of experience in Microbiology, Aseptic manufacturing, Qualification and Validation activities, where he contributed to benchmark and enhance the compliance processes in Pharmaceutical, Biotech, and Life Sciences companies. He has extensive experience in Equipment Qualifications and validations related to Sterile and Non-Sterile manufacturing and Microbiology functions. He is well versed with biotech, aseptic/sterile and non-sterile process technologies and validation processes.

EXPERTISE:

  • Lead Qualification/ Validation Assurance activities, which includes review of activities associated with IQ/OQ/PQ of Equipment and critical utilities.•  
  • Provide QA oversight for aseptic manufacturing and filling operations and implementing global processes.
  • Implement the sterility assurance programs by unit operation specific process mapping, and implementation of CAPA to address the identified gaps. 
  • Conduct investigations into process deviations and problems, and determine appropriate CAPA to prevent recurrences.
  • Lead the simplification and harmonization activities related to manufacturing and microbiology laboratories in alignment with prevailing regulations. 
  • Perform quality reviews of sterilization and aseptic validation and revalidation protocols, including media fills
  • Introduce / review microbiological testing methods that are effective and affordable.  Developed a method for endotoxin testing by KTA method with reduced reagent resulting in 5.2 million USD saving per year.
  • Set up new media fill / environmental monitoring programs; Initiate upgrades of environmental monitoring, media fill and training / QA awareness programs for production operators
  • Conduct audits of Quality Systems to assure compliance with internal SOPs, standards and regulatory requirements.
  • Review QA audit reports for compliance with internal quality standards and SOPs; identify corrective and preventive actions to remediate non-conformances noted during audits
  • Participate in US FDA, EU and other worldwide regulatory agency pharmaceutical inspections as subject matter expert.
  • Develop and deliver GMP training programs and  Design and Implementation of plans to ensure anytime inspection readiness

EXPERIENCE:

  • Last Assignment – Manager, Quality  
  • Worked at Johnson & Johnson Ltd., Baxter Healthcare, Emcure Pharmaceuticals Ltd.,  Glenmark Pharmaceuticals Ltd.,  Serum Institute of India Ltd. in various roles related to Quality Control and Quality Assurance functions.

EDUCATION:

  • Post Graduation Life Sciences


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