Anilkumar Chavan

About Anilkumar Chavan

I, Anilkumar Chavan, working as Senior Executive, Validation in Viatris (Formerly Mylan Laboratories Ltd.) for more than 7.0 years and have a total of 9+ years professional experience in leading regulatory Pharmaceutical, Bio-Pharmaceuticals companies.Commissioning and Qualification (SAT,FAT,IQ, OQ, Cycle development, PQ, RQ) of Aseptic process isolators, steam sterilizers (Autoclaves, terminal sterilizers), Dry heat sterilizers(Tunnel, DHS, Hot air ovens), Complex Injectables equipments (Nanomills, Refiner, Homogenizers, Tanks) Product transfer lines, Process tanks, Lyophilizers, Vial/ Ampoule washing machines, Filling, Sealing machines, CIP, SIP skids, Packing area and QC area equipments, HVAC, LAFs, Utilities(water, nitrogen, steam, compressed air).AREAS OF EXPERTISE1.New sterile projects (utilities, equipments) and process qualifications.2.Sterilization cycles development and qualification.3.Validation quality assurance oversight, including developing quality standards for validation and preparation of protocols and reports.4.Quality assurance of aseptic processing and sterilization. Drug product manufacturing (injectables).5.Quality standards—contributed in the development of quality standards for manufacturing and associated quality operations systems and functions; 6.Design and implementation of systems to support cGMP compliance.7.Exposure to international regulatory authorities (e.g, FDA, MHRA, CDSCO) and quality audits of kemwell biopharm, Mylan.8.QMS (Trackwise)- handling of deviations, change controls, CAPAs, RCIs related to qualification activities.

Experience

1. Senior Executive- Corporate Validation Group

   Viatris

   Mar 2017 — Present · Hosur, IN

   Preparing validation protocols, compilation, and review of documents. Involving in execution of IQ, OQ, CD, PQ and RQ.• Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs.• Coordinates with other departments or outside contractors/vendors to complete validation tasks and Manages projects and prepares status reports.• Qualification & Validation of C&Q of Autoclave.(SIP)·• Qualification & Validation of Manufacturing vessels.(SIP & CIP).• Preparation of annual validation qualification planner and closure of annual validation qualification planner• Validation of utilities like HVAC System, LAFs, Dynamic pass box and Sampling & dispensing booth.• Validation of Product Transfer System and manufacturing Vessels (DDE).• Validation of Inline Homogenizer, High Pressure homogenizer.• Steam Quality test as per plan schedule. • Validation of sterility testing isolator.• Validation of Glove leak tester and rotary heat sealer.• Pre and Post calibration of temperature sensors• Validation of Nano mill• Validation of Refiner.• Temperature mapping for area and equipment.• Qualification & Validation of Pure steam generation & Distribution system.• Airflow visualization studies (Static & Dynamic), NVPC Risk assessments, NVPC Operation simulations.• Participate in audit, compliance and continuous improvement project related activities.• Gap identification and initiating corrective actions by communicating with HOD.• Coordinating with the cross functional team in meetings for qualification activities as per the timelines and Annual validation planner schedule by effective utilization of resources.Project Handled:• Sterile project Division Green field project- 2017 to 2018 (Mylan-India).• Complex injectable green field project- 2020 to 2021 (Mylan India).

Education

• Department of Technical Education, Bangalore

  Diploma in Electronics & Communications Engineering

  2011 — 2013

Skills

• Quality Assurance
• Biotechnology
• Life Sciences
• Calibration
• Glp
• Hplc
• Pharmaceutical Industry
• Sop
• Fda
• Technology Transfer
• Gmp
• Capa