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Tabrezir Mahmood

Tabrezir Mahmood

GxP Computer System Validation Specialist

Pharmaceutical / Bio-tech

Edmonton, Alberta

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Services offered

Validation Engineering Professional with 5+ years of experience in the Pharmaceutical and Biotechnology domain with emphasis as Validation Analyst.

Gxp specialist
Validation engineer
Validation analyst
Approximate rate: CAD$ 50 per hour

Experience

  • Well-acquainted with every phase of the Software Development Life Cycle (SDLC) with extensive experience in working under FDA regulated environments such as GxP regulations, 21 CFR Part 11, 210/211, 820, EU Annex 11, ISPE Gamp5 regulations, and ISO Standards.
  • Participated in developing, reviewing, and documenting Standard Operating Procedures (SOPs), Work Instructions (WI), Project Validation Plans, User Requirement Specifications (URS), and Functional Requirement Specifications (FRS).
  • Participated in Requirement Risk Assessment (RRA), to determine Risk priorities based on Severity, Probability, Risk Class, and Detectability.
  • Experience in authoring and executing Validation Protocols and deliverables such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User/Factory/Site Acceptance Testing (UAT/FAT/SAT) test scripts,  Discrepancy Report (DR), Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR). 
  • Experience in authoring and executing Qualification documents for spectrophotometers and other laboratory equipment, meeting predetermined requirements for accuracy, precision, calibration standards and reliability.
  • Participated in the implementation of Corrective Actions Preventive Actions (CAPA), highlighting, and suggesting remediation plans to mitigate non-compliance.
  • Knowledge of Change Control, Deviation, Gap Analysis, Failure Mode Effective Analysis (FMEA), Root-Cause Analysis (RCA), Data Migration and Periodic Review.
  • Knowledge and Understanding of Good Documentation Practices (GDP) and ALCOA+ principle and their implementation throughout the Data Lifecycle for Data Integrity.
  • Experience in working with systems such as Laboratory Information Management System (LIMS), Compliance wire (LMS), VeevaVault (CMS), TrackWise (QMS), and HP ALM (Automatic Validation Testing Tool).

Experience in Validation of both COTS (Commercial off the Shelves) and Non-COTS (Configured or Custom) systems.

Education

Bachelor of Science in Engineering 
Ahsanullah University of Science & Technology
Dhaka, Bangladesh (2005-2009)

 

Diploma in Business Management 
MacEwan University
Edmonton, AB, Canada (2013-2015)
 

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