Ishit Upadhyay

RA/QA Project Manager at EMCYTE CORP
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Fort Myers, Florida, United States, US

Topline Score

Bio

Generated by
Topline AI

0

/5.0
/ Based on 0 ratings
  • (0)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

No reviews to display There are currently no reviews available.

0

/5.0
/ Based on 0 ratings
  • (0)
  • (0)
  • (0)
  • (0)
  • (0)

Filter reviews by:

No reviews to display There are currently no reviews available.
You need to have a working account to view this content. Click here to join now

Credentials

  • Process Validation
    Axeon Corporation
    Feb, 2022
    - Sep, 2024
  • Implementing the EU’s New Medical Device Regulation (MDR 2017/745)
    Oriel STAT A MATRIX
    Nov, 2020
    - Sep, 2024
  • Lead Auditor ISO 13485
    Axeon Corporation
    Feb, 2021
    - Sep, 2024

Experience

  • EMCYTE CORP
    • United States
    • Medical Device
    • 1 - 100 Employee
    • RA/QA Project Manager
      • Jul 2020 - Present

       Prioritization, planning, project tracking of multiple projects for RA/QA team using JIRA and Primavera P6.  Prepare and maintain Design History Files (DHF).  Compile EU CER reports, EU technical file MDD, EU technical file MDR, and EU MDR PMS reports.  Lead internal audits as per ISO 13485:2016 and FDA 21 CFR 820.  Monitor progress of ongoing projects and help team members achieve desired goal in desired time using the Agile Methodology.  Review statistical data from… Show more  Prioritization, planning, project tracking of multiple projects for RA/QA team using JIRA and Primavera P6.  Prepare and maintain Design History Files (DHF).  Compile EU CER reports, EU technical file MDD, EU technical file MDR, and EU MDR PMS reports.  Lead internal audits as per ISO 13485:2016 and FDA 21 CFR 820.  Monitor progress of ongoing projects and help team members achieve desired goal in desired time using the Agile Methodology.  Review statistical data from the production lines to identify quality problems to develop changes to production processes or quality controls to eliminate the problem using Minitab software.  Prepare reports on detected Non-Conformance Material (NCMR) in process, help to apply preventive/corrective actions.  Perform process and equipment validations, sampling and statistical analysis using Minitab.  Conduct risk assessments and maintain the risk management files.  Initiate stakeholder communications with potential vendors, existing suppliers, and customers. Manage documents and trend analysis for customer complaints.  Keep abreast of new regulations and standards and plan activities for their implementation.  Utilize DMAIC to improve the manufacturing process and reduced the scraps using pareto principle, and fish bone diagram.  Monitor and ensure completion of equipment calibration and validation activities, document releases for ensuring regulatory compliance.  Develop regulatory strategies and implementation plans for the preparation and submission of new products. Show less  Prioritization, planning, project tracking of multiple projects for RA/QA team using JIRA and Primavera P6.  Prepare and maintain Design History Files (DHF).  Compile EU CER reports, EU technical file MDD, EU technical file MDR, and EU MDR PMS reports.  Lead internal audits as per ISO 13485:2016 and FDA 21 CFR 820.  Monitor progress of ongoing projects and help team members achieve desired goal in desired time using the Agile Methodology.  Review statistical data from… Show more  Prioritization, planning, project tracking of multiple projects for RA/QA team using JIRA and Primavera P6.  Prepare and maintain Design History Files (DHF).  Compile EU CER reports, EU technical file MDD, EU technical file MDR, and EU MDR PMS reports.  Lead internal audits as per ISO 13485:2016 and FDA 21 CFR 820.  Monitor progress of ongoing projects and help team members achieve desired goal in desired time using the Agile Methodology.  Review statistical data from the production lines to identify quality problems to develop changes to production processes or quality controls to eliminate the problem using Minitab software.  Prepare reports on detected Non-Conformance Material (NCMR) in process, help to apply preventive/corrective actions.  Perform process and equipment validations, sampling and statistical analysis using Minitab.  Conduct risk assessments and maintain the risk management files.  Initiate stakeholder communications with potential vendors, existing suppliers, and customers. Manage documents and trend analysis for customer complaints.  Keep abreast of new regulations and standards and plan activities for their implementation.  Utilize DMAIC to improve the manufacturing process and reduced the scraps using pareto principle, and fish bone diagram.  Monitor and ensure completion of equipment calibration and validation activities, document releases for ensuring regulatory compliance.  Develop regulatory strategies and implementation plans for the preparation and submission of new products. Show less

  • Northeastern University
    • United States
    • Higher Education
    • 700 & Above Employee
    • Business Analyst
      • Mar 2019 - Jul 2019

       Collaborated with stakeholders to gather and anticipate scope, and objectives to design the Business Requirement.  Documented Functional Requirement Document.  Created BPMN diagram, proposed process, gap analysis using Visio.  Established detailed issues, timeline estimates, and budgets using JIRA to achieve project objectives.  Collaborated with stakeholders to gather and anticipate scope, and objectives to design the Business Requirement.  Documented Functional Requirement Document.  Created BPMN diagram, proposed process, gap analysis using Visio.  Established detailed issues, timeline estimates, and budgets using JIRA to achieve project objectives.

  • Maruti Sales
    • India
    • Consumer Services
    • 1 - 100 Employee
    • Project Coordinator
      • Mar 2015 - Dec 2016

      As a Project Coordinator, I worked on two major projects, implementation of ERP for inventory and supply chain and construction of a new adhesive manufacturing unit.  Built cross-functional teams and managed internal and external collaboration deliverables in a matrix organization.  Planned and Managed projects using both Waterfall and Agile/SCRUM methodologies  Leveraged knowledge with MS Project Server to follow critical path, conduct risk analysis and anticipate and promptly… Show more As a Project Coordinator, I worked on two major projects, implementation of ERP for inventory and supply chain and construction of a new adhesive manufacturing unit.  Built cross-functional teams and managed internal and external collaboration deliverables in a matrix organization.  Planned and Managed projects using both Waterfall and Agile/SCRUM methodologies  Leveraged knowledge with MS Project Server to follow critical path, conduct risk analysis and anticipate and promptly resolve network logic issues.  Collaborated with team members to ensure the overall effectiveness of Earned Value Management (EVM)  Updated Project Dashboard with various reports (Earned Value, burn rate, Resource allocations, Key Milestones, etc.) on a monthly basis using MS Project.  Established a communication schedule to update stakeholders including appropriate staff in the organization on the progress of the project  Formulated key project scope, RAID model, RACI model, Decision Model, and executive presentations to optimize the process of projects  Collaborated with project teams to ensure schedules are accurate and ensured that all the changes and their impacts are accurately reflected in schedules.  Printed 3-weeks look ahead with columns to indicate remaining duration and issue standardized performance reports on EV, SPI, CPI and EAC.

    • Business Development Manager
      • Apr 2014 - Mar 2015

       Plan and implement projects; define project scope, goals and deliverables; define tasks and required resources  Responsible for communicating with stakeholders and customers about pricing, quotes and issues/ concerns.  Accomplished project results by defining project purpose and scope, calculating material required, establishing standards and protocols, allocating resources, scheduling and coordinating staff, evaluating milestone timelines and conclusions, resolving design… Show more  Plan and implement projects; define project scope, goals and deliverables; define tasks and required resources  Responsible for communicating with stakeholders and customers about pricing, quotes and issues/ concerns.  Accomplished project results by defining project purpose and scope, calculating material required, establishing standards and protocols, allocating resources, scheduling and coordinating staff, evaluating milestone timelines and conclusions, resolving design problems.  Contributed to strategizing increment turn over from 7 Million to 7.9 Million.  Improved profit of organization by 14%, P&L Reporting, Presenting ROI  Quote preparation  Introduced the concept of bulk offering.  Working and Practical knowledge of GMP, GLP, ISO.

    • Business Development Associate
      • May 2013 - Apr 2014

       Responsible for managing key clients.  Coordinating with production team to meet the planned targets.  Initiated and looked over a project of small packaging machinery.  Identifying and removing pilferage.  Developed strategies to lessen material loss.

Education

  • Northeastern University
    Master's degree, Project Management
    2018 - 2019

Community

You need to have a working account to view this content. Click here to join now