Vasudha Kumar Email & Phone Number
Who is Vasudha Kumar? Overview
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Vasudha Kumar is listed as Working for Own Startup at Self-employed, based in Pune, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Vasudha Kumar.
Vasudha Kumar previously worked as Assistant Manager RA & QA at Eon Biotechnology and Assistant Manager at Adeetechgene Biotech Pvt Ltd. Vasudha Kumar holds Post Graduate Diploma In Regulatory Affairs, Regulatory Affairs from Mit World Peace University.
About Vasudha Kumar
About 9 years of experience in Quality Assurance and Regulatory Affairs in Pharma/Biotechnology/Medical devices/ IVDsector. Experience in IVDs technical documentation, Dossier compilation, DMF preparation . Documentation as per ISO 13485, MDR, WHO guidelines. Currently working on QA/RA aspect of Rapid Diagnostic Kits for Covid-19 for various regulatory submissions. Experience in QMS, Training and IPQA domain in Pharma sector.
Vasudha Kumar's current company
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Vasudha Kumar work experience
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Assistant Manager Ra & Qa
Assistant Manager
1. Quality and Regulatory documentation and compliance for Rapid diagnostic kits. (SARS-Cov-2)2. DMF creation for the various diagnostic kits as per MDR 2017/ISO 13485:2016.3. Technical documentation ( Analytical validation)4. Dossier compilation for Covid-19 diagnostic kits for various regulatory bodies as per emergency use guidelines/templates.
Freelance Consultant And Trainer
Establishment of QMS system, Traning Module, SOP Preparation, GDP, GWP,
Executive-Quality Assurance
Quality Management System Change control Management, Deviation control, CAPA
Executive - Quality Assurance
1. Control of Master/Obsolete documents.2. Issuance/Preparation of documents.3. Preparation of Standard Operating Procedures for QA and cross functional department.4. Preparation of Batch Manufacturing and packaging record.
Officer - Quality Assurance
Control of Master/Obsolete documents: To ensure timely revision and mastering of documents as per revision period. (SOPs, BMR, BPR, Analytical Work Protocol, Specifications, Method of Analysis). To ensure retrieval of all the distributed copies of the superseded and obsolete documents prior to issue of the revised documents to user departments. Control.
Vasudha Kumar education
Post Graduate Diploma In Regulatory Affairs, Regulatory Affairs
Master Of Science, Biotechnology
Advance Post Graduate Diploma In Clinical Research, Clinical Research
Bachelor Of Science - Bs, Biotechnology
Frequently asked questions about Vasudha Kumar
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What company does Vasudha Kumar work for?
Vasudha Kumar works for Self-employed.
What is Vasudha Kumar's role at Self-employed?
Vasudha Kumar is listed as Working for Own Startup at Self-employed.
Where is Vasudha Kumar based?
Vasudha Kumar is based in Pune, Maharashtra, India while working with Self-employed.
What companies has Vasudha Kumar worked for?
Vasudha Kumar has worked for Self-Employed, Eon Biotechnology, Adeetechgene Biotech Pvt Ltd, Gems Gurukul International School, and Work For Company Ashu Organic & Chemical.
How can I contact Vasudha Kumar?
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What schools did Vasudha Kumar attend?
Vasudha Kumar holds Post Graduate Diploma In Regulatory Affairs, Regulatory Affairs from Mit World Peace University.
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