KHADEER AHMED GHORI
Ottawa,ON
Summary
Driven Quality Engineer with over 5 years of experience in Medical Devices Quality, Regulatory, and Risk Management. Proven record of driving continuous improvement initiatives, change management, and auditing regulatory processes. Reliable and collaborative team player with an ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
8
8
years of professional experience
Work History
SENIOR DESIGN QUALITY ASSURANCE SPECIALIST
Abbott
11.2023 - Current
- Quality reviewed and approved design verification studies supporting 510(k) submission to the US FDA and EU IVDR submission
- Coordinated with cross-functional teams to review clinical and bench studies summaries in support of US FDA 510(k) and EU IVDR submission
- Supported CAPA activities for corrections involving significant change
- Surveilled product complaints and adverse effects reports of on-market Abbott IVD products for safety reporting activities
- Reviewed change control packages of products under development to ensure adherence to Intended product design
- Participated in Abbott's Internal Audit and Notified body Audit for MDSAP (DEKRA)
- Clinical QA Activities: Verified Clinical Line Listings for studies supporting regulatory filings
- Reviewed SOPs and Quality records for identified gaps and ensured compliance
- Surveilled Adverse Device Reports to support device Usability studies and Periodic Safety Update Report (PSUR) activities
CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SPECIALIST
Abbott
06.2021 - 10.2023
- CAPA Activities: Decreased Research and Development Department CAPA/ Quality Event trend by over 90% in 15 months
- Achieved Award of Excellence for contribution to Abbott CAPA mentorship program
- Led Departmental CAPA meetings with Senior Manager of Research and Development to track and trend Departmental CAPA records
- Design and Change Control Activities: Acted as Change originator and led cross-function teams to assess risk and drafted design review meeting minutes
- Supported SOP development arising out of process improvement initiatives and CAPA activities
- Worked on i-STAT Core cartridge verifications to support product maintenance activities
- Worked on Abbott core cartridges and i-STAT 1 and Alinity Instruments Usability Studies involving Human Factors by analyzing Use error-related Adverse Events and relating them to existing Product Risk Documents.
QUALITY, SAFETY, AND RISK ASSOCIATE
Ontario Medical Supply Inc
12.2019 - 06.2021
- Actively Participated in Health Canada cGMP audit and supported ISO 9001-2015 QMS registrar audits resulting in achieving compliant rating for the organization
- Handled 15+ distributed drug products and medical device recalls and field safety corrective actions
- Investigated and resolved Nonconformities Involving High-Value Biologic in liaison with the manufacturer resulting in cost savings of up to CAD 100k
- Investigated product complaints, made recommendations, closed out, trended CAPAs, and analyzed Quality related Key Performance Indicators (KPIs)
- Managed and maintain Quality Assurance SOPs and training records (Document control functions) as per cGMP requirements
- Implemented company-wide training programs.
PHARMACOVIGILANCE OFFICER (Co-op)
CellChem Pharmaceuticals Inc
04.2019 - 12.2019
- Participated in Health Canada Good Pharmacovigilance Practices (GVP) audit and collaborated with Regulatory consultant contributing towards compliance rating to the organization
- Utilized Health Canada Mandatory Adverse Event Reporting form for Industries to report qualifying expedited adverse reactions to marketed drug products
- Prepared Annual Summary Reports (ASRs) and Periodic Safety Update Reports (PSURs) for Marketed Drug Products (DINs) by applying risk-benefit analysis.
SAFETY PROCESS ASSOCIATE
Vigimed Safe Pvt Ltd
03.2016 - 06.2017
- Aided in the Aggregate report's generation in Oracle Argus Database and Signal Detection Activities for multiple drug products
- Triaged and validated drugs and medical devices adverse event reports – ICSRs (Individual case study reports from CRFs) of all types such as spontaneous, clinical trial studies, and solicited programs
- Used Technical writing skills to write case narratives, coded drugs and disease conditions using MedDRA and assessed case causality using WHO standards
- Submitted expedited and periodic reports to concerned regulatory authorities (US FDA, MHRA UK, Health Canada, TGA)
Education
Post Graduate Studies, Regulatory Affairs – Sciences -
Algonquin College
Ottawa, ON04.2019
Post Graduate Studies, Health Care Administration -
Canadore College
Toronto, ON08.2018
Doctor of Pharmacy - PharmD -
Osmania University
Hyderabad, India02.2017
Skills
- FDA QSR, ISO 13485, EU MDR, ISO 9001, ISO 14791, HIPPA, MDSAP
- External Audit support: DEKRA MDSAP, Health Canada cGMP
- TrackWise, MasterControl
- CAPA System, Change Control, ERP: SAP
- Technical Writing
- JMP, Power BI visualization, Mini Tab, EDAT
- Six Sigma
- FMEA, PHMM
- Certified CAPA Auditor
- Non-compliance Assessments
SKILLS
- Organizational Skills
- Project Management
- Product Process Improvement
- Internal and External Audit
- Cross Functional Collaboration
- Analytical and Predictive Thinking
- Data Research
Timeline
SENIOR DESIGN QUALITY ASSURANCE SPECIALIST
Abbott
11.2023 - Current
CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SPECIALIST
Abbott
06.2021 - 10.2023
QUALITY, SAFETY, AND RISK ASSOCIATE
Ontario Medical Supply Inc
12.2019 - 06.2021
PHARMACOVIGILANCE OFFICER (Co-op)
CellChem Pharmaceuticals Inc
04.2019 - 12.2019
SAFETY PROCESS ASSOCIATE
Vigimed Safe Pvt Ltd
03.2016 - 06.2017
Post Graduate Studies, Regulatory Affairs – Sciences -
Algonquin College
Post Graduate Studies, Health Care Administration -
Canadore College
Doctor of Pharmacy - PharmD -
Osmania University
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