Gunja Chaturvedi

Experience

• 

  Biocon

  Jan 2010 - Jun 2016

  Have handled the validation and qualification activities for Clean utilities, FacilityQualification, Autoclave (Tuttanuer), Laminar Air Flow units, Cold room, refrigerator,pH and conductivity meters (Mettler Toledo), Weighing balances, Integrity testingmachines, Dynamic pass boxes and various process equipments like Centrifuge (AlfaLaval), Chromatography systems (Pall), Chromatography Column & Packing Skid(Pall), Harvest storage tank , process docking station, Media preparation systems,Inline buffer dilution systems, tangential flow filtration systems, Viral Filtration Skid(Millipore), Bioreactors (Sartorius and thermo scientific), buffer preparation tanks,cell analyzers, Freeze & Thaw system and Single use bioreactors/ Mixing systems,transfer vessel, Automatic visual inspection machine (Siedenader).- Worked as a part of SAT & FAT activities for equipment qualification.- Handled failure investigations, risk management analysis and Statistical qualitycontrol analysis- Have assisted and faced audits (both customer audits and USFDA audit).- HVAC (Heating ventilation and air conditioning) validation activities.- Have given training and presentations as per the requirements of organization.- Development of Master Validation Plan for the Facility.- Preparation of Validation and revalidation protocols and reports, Riskassessments for qualification/ incidents, IQ/OQ/PQ, Review of URS/ DQ, scheduleand SOPs/EOPs/IOPs, Review of FAT Documents from vendors associated with theequipments and utilities.-Have knowledge about cGMP aspects in Pharmaceuticals/Biopharmaceuticalsindustries- Have knowledge of handling Change control, Deviation Handling, Out ofSpecifications, Corrective Action & Preventive Actions and Review of CTDs.-Have managed project trainees (5+) and guided and assessed their project works. Show less

  • Assistant Manager (QA)

    Aug 2013 - Jun 2016

  • Senior Executive (QA-Validations Compliance)

    Aug 2011 - Jul 2013

  • Executive(QA-Validations Compliance)

    Jul 2010 - Jul 2011

  • Project Trainee

    Jan 2010 - Jun 2010
• 

  Central Drugs Standard Control Organization

  Jun 2016 - now

  • Assistant Drugs Inspector

    Aug 2023 - now

  • Assistant Drugs Inspector

    Jun 2016 - Jul 2023