Bhumi Vyas Email and Phone Number
Having 15+ years of experience in Clinical Research and Digitalisation of Clinical Trial process. Implemented complete paperless digital solution for Phase 1 / BA-BE CRO unitsStarted the career in 2004 with Claris Life science as Validation Officer, where in 1st year received Most Encouraging New Comer and Best employee of the yearFollowed by joining the new industry of Clinical Research Organization Veeda Clinical Research in 2005 as Quality Control Executive and received the best performance awardIn 2006 joined Lambda as Quality Assurance officer for auditing the clinical trials. With the learning capbility got the opportunity to set the Quality systems in Poland and Chennai facility.Handling of more than 75+ insepctions from different regulatory agencies and for different locations of the company a very insightful career growthBeing successful in routine qualty systems in 2009 started a new horizon of digitalization of the company process. This was a new era in Clinical Trial world and made the footprint of CRO in India as transforming all the processes to paperless.In 2018 started the company Clinvigilant with the dream of bringing new aspects in Clinical research, Pharma and Bio to enhance the quality and integrity of the processes through affordable technology and services
Clinvigilant Research
View- Website:
- clinvigilant.com
- Employees:
- 5
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Managing DirectorClinvigilant Research Aug 2017 - PresentIndiaFoundation of ClinVigilant Research Private Limited is inspired by Science & Quality. Bhumi Vyas the founder of the company is having a total of 15+ years of rich experience in the field of Pharmaceutical & Clinical Research Industry. For more details please visit: www.clinvigilant.com
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Head-Quality Process ExcellenceLambda Therapeutic Research Apr 2016 - Feb 2017Ahmedabad Area, IndiaAnalyzing the business processes and streamlining the same in order for better quality & efficiencySkilled in implementing validated software across all locations of LTR for making systems automated in compliance to 21 CFR part 11 & EU Annex 11Expertise in establishing the Quality systemsIdentifying the gaps & implementing the effective CAPAHarmonization of the systems across LTR locationsHandling Regulatory Inspections and sponsor audits/visitsResponding to the regulatory/sponsor queries and ensuring compliance -
Manager-Quality Regulatory AssuranceLambda Therapeutic Research Ltd Apr 2014 - Mar 2016Ahmedabad Area, IndiaExpertise in establishing the Quality systemsIdentifying the gaps & implementing the effective CAPAHarmonization of the systems across LTR locationsHandling Regulatory Inspections and sponsor audits/visitsResponding to the regulatory/sponsor queries and ensuring compliance Skilled in implementing validated software across all locations of LTR for making systems automated in compliance to 21 CFR part 11 & EU Annex 11
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Assistant ManagerLambda Therapeutic Research Apr 2009 - Mar 2014Ahmedabad Area, IndiaUnderstanding of the processes to make systems electronicsPreparation of validation documents like Validation plan, User requirements and validation protocols and reportsExecuting validation as per the pre-defined validation approach in line with GAMP 5Confirming the validation as per U Annex 11 & 21 CFR part 11Review of IT systems & establishment of processes like change management, Incidence Management, disaster & contingency Harmonization of systems across locationsHandling of Regulatory inspection & sponsor Audits
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Assistant Manager-Quality AssuranceLambda Therapeutic Research Limited Oct 2006 - Mar 2009Ahmedabad Area, IndiaAuditing of Clinical Trials at different phases( Pre, ongoing & close out)Auditing of Clinical & Analytical system SOPsAuditing of TMF, SMF, IMP management, analytical documents, reports etcPreparation of Quality Assurance SOPsAuditing of vendor audits like IEC/IRB/hospital sites etcHarmonization of Quality SystemsSupport in regulatory & sponsor audits
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Clinical ResearchVeeda Clinical Research Nov 2005 - Sep 2006Ahmedabad Area, IndiaMonitoring of Phase- I & BA/BE trialsReview of TMF, pharmacy Management, CRF, reports etcMonitoring of online clinical trialsSupport in responding to QA queriesSupport to QA in system audits, process audits & vendor audits -
Qa Validation OfficerClaris Lifesciences, Ahmedabad Jul 2004 - Oct 2005Validation of microbial methodsClean room validation Water system validationHVAC validationToxicology testing
Bhumi Vyas Education Details
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Master Of Science - Ms -
Microbiology -
Bachelor Of Science - Bs
Frequently Asked Questions about Bhumi Vyas
What company does Bhumi Vyas work for?
Bhumi Vyas works for Clinvigilant Research
What is Bhumi Vyas's role at the current company?
Bhumi Vyas's current role is Founder & Director of Quality Assurance at Clinvigilant Research | Digitalization in Clinical Trials | Clinical Operational Services | eClinical Platform | GxP Auditing | Regulatory Audit.
What schools did Bhumi Vyas attend?
Bhumi Vyas attended Sardar Patel University, Gujarat University, Gujarat University.
Who are Bhumi Vyas's colleagues?
Bhumi Vyas's colleagues are Sanjay Paramar, Mili Patel, Mishaal Shahid, Shweta Songire, Tushar Purkar, Amresh Kumar Yadav, Ranjeet D.
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