Experienced professional from Medical device and pharmaceutical background with long experience in QA and RA disciplines.Loves challenges and is a self starter.Currently working as RA Manager at Bio India Interventional Technlogies Pvt.Ltd. a leading player in the Cardiovascular market .Well versed with ISO 13485:2016 as well as the MDR 2017.Currently leading a team to take the company to the next level ,the European MDR.Always looking to convert regulatory challenges to opportunities and raise the bar for internal quality standards.
Bio India Interventional Technologies Pvt Ltd
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Regulatory Affairs Manager At A Leading Medical Device Player In Cardiovascular SpaceBio India Interventional Technologies Pvt Ltd Sep 2020 - PresentIndiaRegulatory Affairs Professional with concurrent experience in Quality Assurance in the Medical Device Industry, dealt with the manufacturing and registration aspects of Class I,II and III medical devices.Also have successfully filed and obtained registration for Active Cardiovascular Device.
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Qa & Ra ManagerSmb Corporation Of India Feb 2018 - Mar 2022Involved in complete gamut of QA and RA related activities including Vendor qualification,Risk Management,CER,Dossier preparation,Batch release,Qualification and Validation programs,PMS ,Complaints handling etc.implementation and monitoring of CAPA.Internal and External audits.Also involved in projects related to upgradation of infrastructure to keep up with GMP requirements. -
Quality Assurance ManagerIgnisol Mediplas Corporation Dec 2014 - Feb 2018Handling QA and QC functions ,dossier preparation,supervision of instrumental and microbial testing including Sterility tests,CAPA,change control,Qualifications and Validations,calibrations -
MicrobiologistAujan Industries Oct 2004 - Feb 2006Plant Microbiological monitoring.Microbiological analysis of RM and Finished products,online QC -
Quality Control OfficerUnilever Mar 1997 - Nov 1999Daman, Daman And DiuOverall incharge of quality for the factory.Supervision of analysis of RM,PM and Finished products.Inprocess analysis of production samples.Internal audits.Coordination with Corporate QA.Handling internal and external audits.Implementation of Unilever Quality Road Map. -
MicrobiologistCiba Ckd Biochem Limited Jul 1997 - Mar 1998Mahad, MaharashtraPlant Microbiologist carrying out environmental monitoring,water analysis ,analysis of RM and Finished Products.Chemical and instrumental analysis of RM,PM and FP. -
Quality Control ChemistGsk Jul 1993 - Jul 1997Nashik, MaharashtraMicrobiological,chemical and instrumental analysis of RM,PM and FP.Microbiological environmental monitoring.Validations of sterile facilities.Trend monitoring .Sterility testing.LAL test.
Sujit Bose Education Details
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Institute Of Pharmacetical ManagementDrug Regulatory Affairs -
Microbiology -
Microbiology, General
Frequently Asked Questions about Sujit Bose
What company does Sujit Bose work for?
Sujit Bose works for Bio India Interventional Technologies Pvt Ltd
What is Sujit Bose's role at the current company?
Sujit Bose's current role is QA and RA Manager with experience from Medical Devices and Pharmaceutical background.
What schools did Sujit Bose attend?
Sujit Bose attended Institute Of Pharmacetical Management, University Of Mumbai, Mumbai University Mumbai.
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Sujit Bose
Gurugram3gmail.com, airvistara.com, indifi.com
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