Experience

Avira Digital

• United States
• IT Services and IT Consulting
• 1 - 100 Employee

• Senior Quality Analyst

  • Jul 2021 - Present

  Avira Digital, technology services firm headquartered in Princeton, NJ, help our clients redefine, reimagine, and reengineer their digital & Data strategy, and make them future-ready.No matter where you are on your digital journey, our innovative services portfolio helps you assess your strategy, plan, agile co-innovation, and implement solutions to realize your success. We are committed to helping our clients, from start-ups to Fortune 500 companies, in your digital x.0 journey. Avira Digital, technology services firm headquartered in Princeton, NJ, help our clients redefine, reimagine, and reengineer their digital & Data strategy, and make them future-ready.No matter where you are on your digital journey, our innovative services portfolio helps you assess your strategy, plan, agile co-innovation, and implement solutions to realize your success. We are committed to helping our clients, from start-ups to Fortune 500 companies, in your digital x.0 journey.



Tetrasoft Inc.

• United States
• IT Services and IT Consulting
• 400 - 500 Employee

• Senior Quality Analyst

  • Sep 2020 - Jun 2021

  For Astrazeneca: Support life sciences customers in the rapid configuration and implementation of Vault Safety. Execute workshops and lead customer discussions of the Vault Development Cloud. Lead gap analyses, workshop preparation and delivery, requirements gathering, configuration, validation, and customer training. Develop, write, and execute validation protocols (IQ/OQ/PQ,etc.), for Veeva Safety Vault. Checking software system installation and accessibility. For Astrazeneca: Support life sciences customers in the rapid configuration and implementation of Vault Safety. Execute workshops and lead customer discussions of the Vault Development Cloud. Lead gap analyses, workshop preparation and delivery, requirements gathering, configuration, validation, and customer training. Develop, write, and execute validation protocols (IQ/OQ/PQ,etc.), for Veeva Safety Vault. Checking software system installation and accessibility.



MakroCare

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Analyst

  • Nov 2018 - Apr 2020

  Review of Clinical Evaluation Reports (CER) and Plans (CEP) as per MEDDEV and EU MDR. Review of Clinical Summary Reports (CSR) as per ICH E3 guidelines. Preparation of Gap analysis Reports as per EU MDR & Quality Manual as per ISO 13485:2016 Management of in-house e Learning Management system and Electronic Document repository. Review of Change controls, Deviation forms and other Quality records. Preparation and Review of SOP’s as required. Updating the regulatory information in the in-house database & in client database. Conduct of Internal Audits and Project specific Audits as per company’s Quality Management System requirements Show less



BLUE NEEM MEDICAL DEVICES PVT LTD

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Officer

  • Jul 2016 - Jun 2018

  Documentation Management process as per the country requirement. Authorising the written procedures and other documents including amendments, Variation as per the country guidelines and Regulatory requirement. Preparation of site master file, Batch index records, Inward QA for raw materials. Preparation and issue of Batch release analysis certificates & COA. Knowledge about ERP administration for medical device module. Rejection / monitoring and approvals of supplier’s materials. Validation of processes and calibration of measuring instruments and devices. Preparation, control and maintenance of documents, formats and records as per EN ISO 13485:2012. ICH guidelines and knowledge about Regulated and ROW market. Preparation of SOP’s site master file as per D & C act and medical device rules 2017. Department wise control SOP’s as per EN ISO 13485:2012 and 21 CFR 820. Show less



Vetindia Pharmaceuticals Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Executive

  • Mar 2013 - Mar 2015

  Handling of core QA functions including Change control reviews, SOP’s review, Logbook review and Documentation. System administration control over the manufacturing equipment. Review of BMR and Release of Batch Activities. Handling of core QA functions including Change control reviews, SOP’s review, Logbook review and Documentation. System administration control over the manufacturing equipment. Review of BMR and Release of Batch Activities.