Rital Patel

Experience

• 

  Dishman Pharmaceuticals & Chemicals Limited

  Nov 2009 - Nov 2013

  Q.C.OFFICER(Microbiologist)

  Worked as a microbiologist where I was responsible to perform microbial activities like bio-burden, environment monitoring (class A,B,C,D), pathogen testing, validation of products and calibration of instruments, water analysis, bacterial endotoxin test, documentation and trend data analysis, preparation and sterilisation of media, Disinfectant efficacy test, Temperature monitoring of lab and instruments, Validation Of steam steriliser by spore strips and ampule, Water sampling and testimg, pathogen testing, Growth promotion Testing, Checking of pH and conductivity of water and products, TOC analysis of water and productsSuccessfully faced various regulatory inspections from USFDA, TGA, EDQM, ISO, WHO-GMP Show less

• 

  Claris Otsuka Pvt Ltd

  Dec 2014 - Sept 2015

  Sr. QA Officer (Microbiologist)

  Worked as a senior microbiologist where I was responsible to perform microbial activities like sterility, bio-burden, environment monitoring (Class A,B,C,D), pathogen testing, validation of products and calibration of instruments, water analysis, bacterial endotoxin test, process simulation, documentation and trend data analysis, preparation and sterilisation of media, Protocol Preparation, Dry heat and moist heat sterilisation validation, product validation ( Sterility, BET, Bio burden), Validation Of HVAC, Holding time validation of products, Area Recovery study of clean room, Actively participated in change control, deviations and OOS.Successfully faced various regulatory inspections from USFDA, TGA, EDQM, ISO, MOH Malaysia and WHO-GMP Show less

• 

  Tréidlia Biovet

  Jan 2016 - Jun 2024

  Quality Manager with 13 years of experience in Pharmaceutical industry.Sound knowledge of Quality management system including, CAPA, Risk Assessment, Deviation Management, OOS investigation, Non Conformities, Document Control, Product Complaints, Recall, Adverse reaction reporting and Management.Team Management, Batch Release. In-process quality control and Quality Assurance System management.Knowledge of Audit Preparations and participated in various regulatory audits like, TGA, APVMA, OGTR, DAWE, MHRA, USFDA.Equipment Validation and Calibrations.Process validation.Product Validation. Microbiological testing(s) of water and productsIQ,OQ,PQ of critical instruments.Water system qualificationAutoclave QualificationHEPA and clean room qualificationEnvironment Monitoring (Viable and Non-viable). Show less

  • Quality Manager

    May 2022 - Jun 2024

  • Quality Team Lead

    Jan 2016 - Apr 2022
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  Troy Animal Healthcare

  Jun 2024 - now

  QA/Compliance Specialist