Suresh Kumar Kadiri

Experience

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  Aurobindo Pharma

  Mar 2007 - May 2009

  Microbiologist

  Aurobindo Pharma Ltd, Unit VI is a largest manufacturer of Cephalosporin injectables, orals and sterile API.As a Microbiologist I am involved in…..1. Environmental monitoring of classified and controlled areas.2. Water sampling and water analysis (MLT, BET, TOC, LBPC, PH and Conductivity).3. Preparation and review of trends for water and environmental monitoring with respect to regulatory environment.4. Microbial identification by using mini API - Biomerieux. 5. Involved in all production related validations (Aseptic media simulation study (Media fill), Cleaning validations, Inprocess monitoring, Equipment hold time validations etc.).6. Involved in the success of various regulatory audits like USFDA, MOH, MHRA, WHO etc, and also various customer audits. Show less

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  Eisai EMEA

  Jun 2009 - Jun 2010

  Executive microbiologist

  Eisai Pharmatechnology and Manufacturing Pvt. Ltd. is a Japan based MNC Company manufacturer of oral dosage forms and bulk API products (Aricept, Myonal etc,) at Visakhapatnam.As an executive Microbiologist here I involved in…….1. Procurement, assessment and qualification (IQ, OQ and PQ) of new microbiology related equipments and its regular maintenance.2. Preparation of SOPs, GTPs, Specifications, IQ, OQ, PQ and Validation protocols.3. Validation and calibration of all Microbiology instruments.4. Preparation and maintenance of Microbiological pure cultures and growth media.5. Microbial limit tests for raw materials, finished oral drug products and water samples. 6. Microbial identification by using ATB - Biomerieux.7. Approved competent technical staff for the Drug product of Donepezil Hydrochloride – Aricept.Achievements:8. Completed the set up of microbiology laboratory from initial stage to analysis stage.9. Qualified the water system and production facilities of Oral dosage forms and API. Show less

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  Dr. Reddy's Laboratories

  Jun 2010 - Jun 2014

  Assistant Manager

  Dr. Reddys laboratories Ltd, Biologics development center is dedicated to the development and manufacturing of biosimilars (Grafeel (Filgrastim), Reditux (Rituximab), Cresp (Darbepoetin alpha) and Peg Grafeel (Peg Filgrastim)). As an Assistant manager - Microbiology here my job responsibilities includes...1. Sterility testing of Drug product, Drug substance and Packing materials.2. Bacterial Endotoxin test by Gel clot and kinetic methods (Kinetic Turbidimetric Assay / Kinetic Chromogenic Assay) for Drug products, Drug substance, Raw materials and Water samples.3. Microbial identification by using Vitek 2 Compact Microbial identification system - Biomerieux.4. Preparation & Maintenance of microbial Library and detailed investigation of microbial excursions (Contamination samples, Environmental monitoring, Water system and Sterility failures).5. GLP maintenance and implementation of cGMP guide lines at practice.6. Comprehensive experience in implementation and maintenance of documentation as per the regulatory norms, Quality procedures and review for its effectiveness. 7. Microbiological evaluation of Master cell bank and Working cell bank and determination of microbiological purity of fermentation culture samples.8. Training of personnel with respect to GLP, cGMP, Aseptic area qualifications and on job training of microbiologists.9. Method validations for Sterility, BET and microbiology related production validations (Aseptic media simulation study (Media fill), Cleaning validations etc.).10. Handling of CAPA, change controls and discrepancies.11. Detailed investigation of product failures and market complaints.12. As a member of ERT (Emergency Response Team - Safety) responsible for built up Emergency awareness among team members.13. Involved in implementation rapid BET (KTA, KCA & Endosafe PTS) for endotoxin testing as alternative to Gel clot method. Show less

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  MSN Laboratories

  Jul 2014 - Feb 2016

  Assistant Manager

  MSN GROUP OF COMPANIES is one of the fastest growing pharmaceutical companies in India. Boosting a diverse product portfolio of multiple products (API and sterile finished dosages). It is approved for WHO: GMP, EU: GMP and USFDA.As an Assistant manager (Team leader) Microbiology here my job responsibilities includes...1. Planning and allocation of work with smooth execution among the team members.2. Laboratory capex, budget planning and procurement of consumables.3. New equipment selection, URS, DQ, Procurement, FAT, SAT, IQ, OQ and PQ for establishment of new Microbiology laboratory.4. Initiation and review of Microbiology related documentation.5. Review and inspection of Raw materials, finished products, environmental and water samples testing. Review and approval of calibration data, validation data, stability data, water trends and environmental trends.6. Handling of microbiology related market complaints, change controls, deviations, OOT, OOS and CAPA.7. Establishing method development and validations for BET and MLT of products, microbiology related studies, qualifications and validations.8. Integrating continuous improvement on GLP/GMP concepts and techniques in to all aspects of the microbiology lab.9. Monitoring and approval of validation, calibration and preventive maintenance program for laboratory equipments and instruments.10. Maintenance of Microbiology laboratory with anytime audit readiness, follow up and addressal of customer audits and regulatory audits, execution of vendor audits. Show less

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  Mylan Laboratories Limited

  Feb 2016 - Jul 2017

  Senior Microbiologist

  Mylan Laboratories Limited is an US based company emerging in India.Here in Injectable division I am being apart of....1. Microbiology Technology transfer, 2. QRM and QMS,3. EU and ANDA submissions and Addressing of Regulatory queries, gaps and potential risks,5. Conducting Trainings to the team members.6. Microbial Method development, suitability, validation and verification of Sterility, BET, MLT and AET methods for all products related to sterile injectable manufacturing facilities of Mylan laboratories limited, Bangalore. Show less

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  Aurobindo Pharma

  Aug 2017 - now

  Deputy Manager

  Microbiology laboratory establishment (green field project) for supporting the oncology products. Development and validation of the microbiological methods for new drug molecules.Ensuring the microbiology laboratory compliance with "any time audit readyness".