Jalpa Patel
Medical Safety Data Analyst, Risk Management | Quality Assurance & Compliance Expert | Regulatory Affairs Specialist | Medical Device & Pharmaceutical Industries L Health Technology L Innovation
Overview
14
14
years of professional experience
Work History
Global Medical Safety Data Analyst
BD
Franklin Lake
9 2020 - Current
- Ensured compliance with MSRB Process by leading monitoring and maintenance activities, and reporting outcomes to management
- Reviewed and analyzed critical complaints, identifying potential emerging safety indicators from monthly post-market data
- Conducted in-depth dashboard analyses to identify safety signals, spearheading enhancements to the MSRB process
- Conducted dashboard analyses to improve MSRB processes
- Identified patterns and trends in complaints and adverse events data to uncover potential emerging safety indicators
- Recognized potential problems and took preventive steps, recommending solutions for complex issues
- Asserted ideas and persuaded others to implement improvements
- Utilized Minitab to create a 3-month moving average of Malfunction MDRs, presenting findings to Pre-MSRB
- Created the Global Medical Safety (GMS) Metrics presentation, compiling data for Death or Serious Injury MDRs (DORSI), Situation Analysis & Health Risk Analysis (SA/HRA), and Field Action (FA)
- Maintained and updated SA/FA/HRA Summary of Safety & Performance
- Coordinated with QA/RA departments to complete MSRB and metrics reports; ensured accurate information on DORSI and SA/HRA/Field Action dashboards
- Supported safety and risk management by updating Health Risk Assessments and Benefit Risk Assessments
- Analyzed and evaluated monthly Rotarex complaints to identify potential impacts on patients
- Works with manager to understand full needs of Medical Affairs (MA) function as it relates to Post Market Surveillance (PMS) Program and annual Post Market Surveillance activities (PMS Plan and Periodic Safety Update Report, PSUR) for Pre-Medical Safety Review Board (MSRB) and the Global Medical Safety (GMS) Metrics presentation by compiling relevant data
- Created comprehensive reports and submitted them to the manager for review and assessment
- Managed multiple projects, organizing and prioritizing assignments to meet regulatory and operational demands
- Interacted with management to provide updates, discuss issues, and propose resolutions
- Ensured that high-quality reports were compiled and reviewed in compliance with regulatory requirements and project timelines
- Followed up with cross-functional data owners for clarification as needed
- Managed activities with minimal supervision, providing frequent updates to management, discussing issues, and proposing resolutions.
QA, Compliance Specialist
Hitachi Chemical Advance Therapeutic solution
Allendale
04.2020 - 08.2020
- Develops and communicates investigation strategy to key stakeholders
- In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log
- Reviews and approves investigations and CAPAs
- Conducts weekly status update meetings with cross functional departments and other stakeholders
- Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis
- Prepares and issues change control as necessary
- Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures
- Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations
- Participates in regulatory compliance audits and inspection
- Facilitates meetings and escalations
- Leads investigations, as necessary
- Conducts trend analysis of compliance related metrics such as deviations and CAPAs
- Performs supplemental investigations and/or participates in project teams or assignment as necessary
- Support in agency, internal and/or client audits
- Other duties as assigned.
Complaint Analyst
Getinge Group
Wayne
10.2016 - 04.2020
- Responsible for to review and close completed failure investigation in Trackwise
- Responsible for the review and reporting/submitting Initial and Follow up Medical Device Reports
- Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries
- Collecting follow up information related to complaints from customers and Sales Representatives if needed
- Investigates customer complaints, makes an initial reporting decision, and ensures completeness, consistency of complaint and related documentation and the triaging of complaints requiring additional failure investigations; root cause and corrective/preventive action (CAPA) determination
- Responsible to review DHR (Device History Report) for particular serial number of the unit
- Responsible for communicating business related issues and quality and compliance issues to next management level
- Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending
- Responsible for analyzing post market data to create reports which needed to create post market surveillance reports (PMS)
- Support the administration of the CAPA system, working with other areas of the organization to ensure processes are following and timely closure of open CAPA files
- Run the complaints query to provide data based on FDA requirement to the Regulatory department
- Demonstrated willingness to take initiative and become directly involved in planning, problem solving, and execution of work in a team environment.
QA, Compliance Specialist
G & W Laboratories Inc.
South Plainfield
06.2015 - 10.2016
- Initiating investigations in the TrackWise system to address quality incidents and deviations
- Ensuring final product release and customer product’s release in the Oracle system
- Preparing, reviewing, and maintaining all standard operating procedures (SOPs) and associated forms
- Handling Corrective and Preventive Actions (CAPA) related to products and conducting investigations for market complaints, updating them in the TrackWise system
- Responsible to input batch record data for product trend analysis and maintain departmental metrics
- Involved in customer audits and leading internal audits
- Leading operation excellence projects such as reduction of batch record review cycle time, redesign of batch record to reduce the human error etc
- Managing the incoming material inspection team in the absence of the Quality Manager, ensuring timely release of raw materials for production
- Providing submission batch-related documents to support the regulatory department
- Conducting Annual Product Reviews (APR) to assess product quality and compliance
- Performing quality reviews of batch records and packaging records as needed
- Reviewing Certificates of Analysis (COAs) and QC Finish Product Lab Releases
- Initiating and participating in Kaizen events to improve product release processes
- Serving as a subject matter expert for designated Quality Management System (QMS) elements during regulatory compliance audits and inspections.
Quality Assurance Specialist
Amneal Pharmaceutical Ltd.
Branch brook
10.2014 - 02.2015
- Reviewed and assessed Deviations & Change Controls, including evaluation, tracking, follow-up, reporting and trending and closing
- Received all customer complaints, update it into the spreadsheet and forward it to the appropriate department for investigation
- Reviewed and approved Validation and Technical Reports
- Responsible for the Monthly internal audit
- Responsible for preparation, circulation, and handling of all standard operating procedures (SOPs) and associated forms
- Handled of CAPA related to products
- Ability to work on complex Quality projects
- Knowledge of SAP Software and hands on the QUMAS software.
Quality Assurance Supervisor
Zydus Cadila Healthcare Ltd.
07.2010 - 11.2013
- Responsible for investigation and evaluation of product failure & market complaints
- Lead the Team for Pre-Audit Process which involves communication with production team and task assignment for the team members
- Demonstrated advanced problem solving skills through the use of quality
- Leading Complaint investigation team for reported Market complaints Reviewed of filled Batch Manufacturing Records (BMR), Batch Packing Records (BPR) and SOPs
- Prepared Annual product quality review (APQR) related to oral solid dosage forms
- Handled Deviations, Change controls, CAPA related to products, systems and documents and its closure
- Prepared validation summary reports
- Tracked of Self inspection as per schedule and review of compliance with cGMP
- Ability to effectively work within a team and cross functionally to expedite completion of critical project tasks.
Education
Bachelors of Pharmacy -
Gujarat University
Skills
Extensive working knowledge of Medical affairs, Quality Assurance, Risk Management, Regulatory, or Quality Compliance and Regulatory Affairs activities in a Medical Device and Pharmaceutical company
Knowledge and understanding of FDA regulations, ISO standards, EU MDR/IVDR, and other industry standards for medical devices
In-depth knowledge of domestic and international Medical Device Regulations, including EUMDR, ISO 13485, cGMP, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), 21 CFR Part 820- Quality System Regulation, and 21 CFR Part 11 Working knowledge of standards applicable to business unit products
Experienced in managing Post-Market Surveillance activities, including PMS Plans, MSRB, and GMS Metrics Presentations
Skilled in writing, reviewing, and approving SOPs in TrackWise, and reviewing Analytical Methods, Validation Protocols, Stability Protocols, Product Development Reports, Scale-up Reports, Deviation Reports, and Product Complaints
Proficient in conducting and managing internal QA audits, overseeing document control, implementing change control, and conducting thorough failure investigations
Familiarity with In Vitro Diagnostics in a clinical or academic setting and knowledge of Medical/Technical Terminology
Proficient in using Microsoft Power BI for creating presentations and utilizing data from dashboards
Experienced with Minitab for Statistical Analysis and Data Interpretation
Handes on Excel pivot table and ability to create chart from the data as per business need
Proactive problem-solving skills with strong Critical Thinking, Strategic Assessment, and Analytical abilities
Proven ability to work independently and manage multiple projects with minimal supervision
Self-motivated team player with strong Project Management skills and the ability to work effectively in team environments
Quick judgment and decision-making abilities
Excellent Communication, Interpersonal, and Collaborative skills
Strong writing skills, summarization skills, and accuracy in Documentation and Record-Keeping practices; technical and scientific writing experience
Strong inter-department coordination skills, Time Management, and Activity Management
Fosters collaboration among team members
References
Reference will be available based upon request.
Timeline
QA, Compliance Specialist
Hitachi Chemical Advance Therapeutic solution
04.2020 - 08.2020
Complaint Analyst
Getinge Group
10.2016 - 04.2020
QA, Compliance Specialist
G & W Laboratories Inc.
06.2015 - 10.2016
Quality Assurance Specialist
Amneal Pharmaceutical Ltd.
10.2014 - 02.2015
Quality Assurance Supervisor
Zydus Cadila Healthcare Ltd.
07.2010 - 11.2013
Global Medical Safety Data Analyst
BD
9 2020 - Current
Bachelors of Pharmacy -
Gujarat University