Tanushree Chowdhury
Ichapore
Summary
To Work in a Challenging Environment that provides generous opportunities for learning. Secure a responsible career opportunity to utilize my training and skills, while making a significant contribution to the success of the company.
Overview
7
7
Certifications
1
1
Language
Work History
Senior Process Executive (SPE)
Cognizant Technology Solutions
- Current
- I am Currently working at Cognizant Technology Solution as a Senior Process Executive (SPE) with 6 years and 2 months of experience. In below job details are provided.
- Complaint Handling Group (Medical Device)
- TJDA
- Coordinating all complaint handling function.
- Hand on experience in TrackWise application and MS- Office Application.
- Establishing and maintaining procedures for receiving, reviewing, and evaluating complaints.
- Delegation of responsibility of components of complaint handling to appropriate functional units Reviewing, evaluating, and investigating any complaint involving the possible failure of a product, labelling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
- CAPA/Risk Assessment &Closure of cases (Medical Device)
- Senior Process Executive(SPE)
- Understanding CAPA Process steps related to quality issue in medical Device.
- Determine and delegate the necessary action items to the responsible teams/Individuals and drive them to meet the KPI Targets.
- Hand on experience in Problem solving tools (8D, VLOOKUP, Graph, pivot)
- Responsible for product safety risk management deliverables and Maintenances Risk Management file during product development and during lifecycle management as per ISO 14971 and product specific regulations and standards.
- Performed closure of the cases after investigation as per SOP by double checking the level of adverse effect and identifying the late adverse event that need to be reportable.
- Supported for Ad hoc activities and Quality Review.
- Receive and evaluate product complaints for FDA, EU, Canadian and other Health Regulatory Authorities as required for reporting requirements.
- Take responsibility for maintaining efficient Medical Device Report workflow and work assignments to achieve complete and timely closures.
- Medical Event Group (Regulatory Affair-Medical Device)
- Senior Process Executive(SPE)
- Monitor post product data (complaints, Corrective and preventive action (CAPA), Non-conformance reports, customer feedback information, etc) for impact to the risk management file.
- Prepare and submit all MedWatch Reports, both Initial and Follow- up reports, to the FDA in compliance with regulations, guidelines, and the required timeframe.
- Conducted the non-reportable and reportable submissions to regulatory authorities as per guidelines.
- Assure that medical reviews and reportability reviews are completed in a timely manner for submission.
- Assure accuracy, integrity, completeness, and consistent content of all product complaint investigations and MDR and Vigilance reports.
- Participate in FDA and ISO audits if required or as needed.
- SME in DHR Pilot Project (Medical Device History Record)
- Senior Process Executive(SPE)
- Investigation of devices as per US-FDA guidelines and submit the report to regulatory authority validation.
- Data Validation, Data Reconciliation and Data Cleaning by peer- Reviewing
- Evaluation of complaints and identify the adverse events related to the device according to SOP, investigate the devices, submission of the adverse events and close out the case after completing the investigation.
- Conducting the investigation for Device history record by use of various databases such as Oracle Toad and various client’s specific data bases and completing the investigation for submission in us- FDA.
- Quality review, Mentoring of OJT Associates, Team management, Client Call handling.
- Allocation of cases to teams as per project requirements on regular basis.
- Maintaining databases for clients, tracking, and conducting Adhoc activities to complete before the deadline.
Education
M.Sc - Clinical Nutrition Management and Dietetics
BARRACKPORE RASTRAGURU SURENDRANATH COLLEGE
01.2018
B.Sc - Food and Clinical Nutrition Hons.
BARRACKPORE RASTRAGURU SURENDRANATH COLLEGE
01.2016
HS - English, Physics, chemistry, Biology, Math
K.V.NO.2 ISHAPORE(CBSE)
01.2013
Madhyamik - English, Hindi, science, social studies, Math
K.V.NO.2 ISHAPORE(CBSE)
01.2011
Skills
- Knowledge and understanding of regulations related to risk management and the development of safe software and hardware product including ISO 14971, FDA Regulation 21 CFR 820, 21 CFR - Part 11, EU MDR
- ICH-GCP and other regulatory Guidelines
- Risk Analysis Methodology (FMEA)
- Clinical Trail Phase (Phase I to IV)
- Clinical Data Management activities
- Interpersonal skills and experience in creating risk management deliverables
- Detailed Knowledge on Clinical Nutrition and Dietetics
- Data Reconciliation and Data Cleaning by peer-Reviewing
Certification
ISO 14971: 2019 Medical Devices -Risk Management (Online Training)
Interests
Singing, reading books, Listening to good music, Travel
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge.
Personal profile
- Father’s name: Tarun Kumar Chowdhury
- Date of birth: 14th September, 1995
- Nationality: Indian
- Religion: Hinduism
- Gender: Female
- Strength: Enthusiastic, Dynamic and Leadership
Timeline
Senior Process Executive (SPE)
Cognizant Technology Solutions
- Current
B.Sc - Food and Clinical Nutrition Hons.
BARRACKPORE RASTRAGURU SURENDRANATH COLLEGE
HS - English, Physics, chemistry, Biology, Math
K.V.NO.2 ISHAPORE(CBSE)
Madhyamik - English, Hindi, science, social studies, Math
K.V.NO.2 ISHAPORE(CBSE)
M.Sc - Clinical Nutrition Management and Dietetics
BARRACKPORE RASTRAGURU SURENDRANATH COLLEGE