Tanvi Routela
Quality Assurance Specialist at Prodct- Claim this Profile
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Bio
Heather Puksta
Tanvi and I worked together at iVexSol for over a year. She is an incredibly passionate professional, and enjoys learning and growing. Tanvi supported implementing a new eQMS (Veeva) and a new LMS (ComplianceWire) and learned both systems like a champ. She ran projects as a PM, and did a great job keeping everyone on-task to get things done. Tanvi also designed a few Quality System elements for a new QMS system and did a fantastic job writing them in a phase-appropriate fit-for-OUR-purpose manner. Tanvi's drive and dedication is an asset to any team, and I hope to have the opportunity to work with her again in the future. If you are looking to work with Tanvi and need a referral, please feel free to call me - I'd be happy to share my experience.
Rob MacCuspie
Tanvi is an excellent team member. Accomplishing leadership tasks including researching international medical device regulatory landscapes, providing decision-making information for regulatory strategy, and internally leading international regulatory approval submission preparations, while organizing documentation systems and developing project management dashboards to track progress. Tanvi is hard working, intelligent, and gets along great with other team members.
Heather Puksta
Tanvi and I worked together at iVexSol for over a year. She is an incredibly passionate professional, and enjoys learning and growing. Tanvi supported implementing a new eQMS (Veeva) and a new LMS (ComplianceWire) and learned both systems like a champ. She ran projects as a PM, and did a great job keeping everyone on-task to get things done. Tanvi also designed a few Quality System elements for a new QMS system and did a fantastic job writing them in a phase-appropriate fit-for-OUR-purpose manner. Tanvi's drive and dedication is an asset to any team, and I hope to have the opportunity to work with her again in the future. If you are looking to work with Tanvi and need a referral, please feel free to call me - I'd be happy to share my experience.
Rob MacCuspie
Tanvi is an excellent team member. Accomplishing leadership tasks including researching international medical device regulatory landscapes, providing decision-making information for regulatory strategy, and internally leading international regulatory approval submission preparations, while organizing documentation systems and developing project management dashboards to track progress. Tanvi is hard working, intelligent, and gets along great with other team members.
Heather Puksta
Tanvi and I worked together at iVexSol for over a year. She is an incredibly passionate professional, and enjoys learning and growing. Tanvi supported implementing a new eQMS (Veeva) and a new LMS (ComplianceWire) and learned both systems like a champ. She ran projects as a PM, and did a great job keeping everyone on-task to get things done. Tanvi also designed a few Quality System elements for a new QMS system and did a fantastic job writing them in a phase-appropriate fit-for-OUR-purpose manner. Tanvi's drive and dedication is an asset to any team, and I hope to have the opportunity to work with her again in the future. If you are looking to work with Tanvi and need a referral, please feel free to call me - I'd be happy to share my experience.
Rob MacCuspie
Tanvi is an excellent team member. Accomplishing leadership tasks including researching international medical device regulatory landscapes, providing decision-making information for regulatory strategy, and internally leading international regulatory approval submission preparations, while organizing documentation systems and developing project management dashboards to track progress. Tanvi is hard working, intelligent, and gets along great with other team members.
Heather Puksta
Tanvi and I worked together at iVexSol for over a year. She is an incredibly passionate professional, and enjoys learning and growing. Tanvi supported implementing a new eQMS (Veeva) and a new LMS (ComplianceWire) and learned both systems like a champ. She ran projects as a PM, and did a great job keeping everyone on-task to get things done. Tanvi also designed a few Quality System elements for a new QMS system and did a fantastic job writing them in a phase-appropriate fit-for-OUR-purpose manner. Tanvi's drive and dedication is an asset to any team, and I hope to have the opportunity to work with her again in the future. If you are looking to work with Tanvi and need a referral, please feel free to call me - I'd be happy to share my experience.
Rob MacCuspie
Tanvi is an excellent team member. Accomplishing leadership tasks including researching international medical device regulatory landscapes, providing decision-making information for regulatory strategy, and internally leading international regulatory approval submission preparations, while organizing documentation systems and developing project management dashboards to track progress. Tanvi is hard working, intelligent, and gets along great with other team members.
Credentials
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Experiential Network
Northeastern University
Experience
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Prodct
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United States
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Business Consulting and Services
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1 - 100 Employee
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Quality Assurance Specialist
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Oct 2023 - Present
Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments. Prodct creates bespoke development, quality, and manufacturing strategies aligned with 21 CFR part 820, 21 CFR part… Show more Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments. Prodct creates bespoke development, quality, and manufacturing strategies aligned with 21 CFR part 820, 21 CFR part 11, ISO 13485:2016 and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary. Prodct helps create and communicate value for growing organizations through external expectation management with partners, developers, manufacturers, and investors. Show less Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments. Prodct creates bespoke development, quality, and manufacturing strategies aligned with 21 CFR part 820, 21 CFR part… Show more Prodct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments. Prodct creates bespoke development, quality, and manufacturing strategies aligned with 21 CFR part 820, 21 CFR part 11, ISO 13485:2016 and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary. Prodct helps create and communicate value for growing organizations through external expectation management with partners, developers, manufacturers, and investors. Show less
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iVexSol
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United States
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Biotechnology
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1 - 100 Employee
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Quality Compliance Specialist
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Sep 2022 - Aug 2023
• Led Standards Compliance assessment of the company to GLP (21 CFR 58) requirements and subsequently, led a remediation project to ensure compliance. • Implemented ComplianceWire Learning Management System and developed supporting procedures, forms, and infrastructure documentation. • Developed QMS programs including Deviation, CAPA Issue Reporting and Root Cause Analysis. • Supported Veeva Vault implementation and developed supporting procedures, forms, and infrastructure… Show more • Led Standards Compliance assessment of the company to GLP (21 CFR 58) requirements and subsequently, led a remediation project to ensure compliance. • Implemented ComplianceWire Learning Management System and developed supporting procedures, forms, and infrastructure documentation. • Developed QMS programs including Deviation, CAPA Issue Reporting and Root Cause Analysis. • Supported Veeva Vault implementation and developed supporting procedures, forms, and infrastructure documentation. • Initiated the Issue Intake Process and lead early investigation.
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Quality Analyst
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Jul 2021 - Sep 2022
• Administered document control system, paper-based training, and tracking tools. • Built paper-based training program and ensured all individuals were appropriately trained. • Supported the creation and implementation of Policies and SOPs including but not limited to Risk Management, Training, and Controlled Documents and Records. • Provided project management support with vendors to ensure on-time delivery of projects. • Implemented process improvements to enhance compliance and… Show more • Administered document control system, paper-based training, and tracking tools. • Built paper-based training program and ensured all individuals were appropriately trained. • Supported the creation and implementation of Policies and SOPs including but not limited to Risk Management, Training, and Controlled Documents and Records. • Provided project management support with vendors to ensure on-time delivery of projects. • Implemented process improvements to enhance compliance and prepare reports to communicate outcomes of quality activities to other cross-functional teams. • Performed Computer software validation activities as per 21 CFR 11: Electronic records.
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Folia Materials
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United States
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Paper & Forest Products
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1 - 100 Employee
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Regulatory Affairs and Quality Assurance Associate
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Mar 2021 - Jul 2021
• Oversee all regulatory and quality assurance activities within the company timeline and with internal procedures and legislative requirements. • Identified, completed, and filed all necessary documentation as required with applicable regulatory bodies, both domestic and international for product registrations • Analyzed and established QMS systems including SOP documentation, record keeping, and creating new procedures and processes for 2 product lines. • Reviewed device labeling… Show more • Oversee all regulatory and quality assurance activities within the company timeline and with internal procedures and legislative requirements. • Identified, completed, and filed all necessary documentation as required with applicable regulatory bodies, both domestic and international for product registrations • Analyzed and established QMS systems including SOP documentation, record keeping, and creating new procedures and processes for 2 product lines. • Reviewed device labeling, advertised materials and packages in accordance with submission regulatory requirement by working in cross-functional teams • Assisted in the translation of international regulatory documents, submission packages review, and submission to COFEPRIS Show less • Oversee all regulatory and quality assurance activities within the company timeline and with internal procedures and legislative requirements. • Identified, completed, and filed all necessary documentation as required with applicable regulatory bodies, both domestic and international for product registrations • Analyzed and established QMS systems including SOP documentation, record keeping, and creating new procedures and processes for 2 product lines. • Reviewed device labeling… Show more • Oversee all regulatory and quality assurance activities within the company timeline and with internal procedures and legislative requirements. • Identified, completed, and filed all necessary documentation as required with applicable regulatory bodies, both domestic and international for product registrations • Analyzed and established QMS systems including SOP documentation, record keeping, and creating new procedures and processes for 2 product lines. • Reviewed device labeling, advertised materials and packages in accordance with submission regulatory requirement by working in cross-functional teams • Assisted in the translation of international regulatory documents, submission packages review, and submission to COFEPRIS Show less
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Sen-Jam Pharmaceutical
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United States
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Wellness and Fitness Services
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1 - 100 Employee
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Experiential Network Project- Regulatory Strategy Lead
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Sep 2020 - Dec 2020
• Created and maintained Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported • Assisted in the development of multi-country regulatory strategy for LATAM countries • Guided regulatory management in the implementation and delivery of CMC regulatory documentation • Participated in cross-functional teams by working closely with product development engineering, marketing, clinical, and… Show more • Created and maintained Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported • Assisted in the development of multi-country regulatory strategy for LATAM countries • Guided regulatory management in the implementation and delivery of CMC regulatory documentation • Participated in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions •Prepared and submitted internal regulatory file applications and supporting documentation Show less • Created and maintained Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported • Assisted in the development of multi-country regulatory strategy for LATAM countries • Guided regulatory management in the implementation and delivery of CMC regulatory documentation • Participated in cross-functional teams by working closely with product development engineering, marketing, clinical, and… Show more • Created and maintained Regulatory submission timelines, reports, and trackers with general instruction and ensure that they are functional, consistent, and adequately supported • Assisted in the development of multi-country regulatory strategy for LATAM countries • Guided regulatory management in the implementation and delivery of CMC regulatory documentation • Participated in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions •Prepared and submitted internal regulatory file applications and supporting documentation Show less
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Freyr Solutions
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Experiential Network Project- Regulatory Affairs
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Jan 2020 - Mar 2020
•Coordinated in creating a regulatory tool called Freyr iREADY which serves as a centralized cosmetic ingredient database •Assisted companies with determining the impact if a new ingredient change on existing products •Indexed and verified various sample ingredients in ChemID plus •Conducted regular QC checks to ensure SOP compliance and precise documentation •Coordinated in creating a regulatory tool called Freyr iREADY which serves as a centralized cosmetic ingredient database •Assisted companies with determining the impact if a new ingredient change on existing products •Indexed and verified various sample ingredients in ChemID plus •Conducted regular QC checks to ensure SOP compliance and precise documentation
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National Research Center on Plant Biotechnology
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IT Services and IT Consulting
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1 - 100 Employee
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Research Assistant
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Nov 2017 - Apr 2018
• Conducted a research involving over expression of chitinase gene in E.coli and studied its effects on Alternaria Brassicae in vitro. • Documented 60 page thesis of laboratory procedures and necessary information about noble work. • Performed gene clowning experiments and increased volume of cultures by doing bacterial transformation. • Performed DNA gel electrophoresis for confirmation, colony PCR and over expression was confirmed by performing SDS page and an enzyme assay. • Conducted a research involving over expression of chitinase gene in E.coli and studied its effects on Alternaria Brassicae in vitro. • Documented 60 page thesis of laboratory procedures and necessary information about noble work. • Performed gene clowning experiments and increased volume of cultures by doing bacterial transformation. • Performed DNA gel electrophoresis for confirmation, colony PCR and over expression was confirmed by performing SDS page and an enzyme assay.
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Food Corporation Of India
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India
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Government Administration
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700 & Above Employee
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Quality Control Intern
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Dec 2016 - Jan 2017
• Analyzed differences of food grains from India and other countries • Performed various quality audits and comparison studies • Identified causes for multiple QA/QC defects including GMP, ISO, QSR. • Coordinated daily laboratory activity with supervisor such as designing experiments, analyzing data • Analyzed differences of food grains from India and other countries • Performed various quality audits and comparison studies • Identified causes for multiple QA/QC defects including GMP, ISO, QSR. • Coordinated daily laboratory activity with supervisor such as designing experiments, analyzing data
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Education
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2019 - 2020
Northeastern University
Master's degree, Regulatory Affairs for Drugs, medical devices and biologics -
2014 - 2018
Vellore Institute of Technology
Bachelor of Technology - BTech, Biotechnology
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