Razi Uddin, Cqe Candidate Email & Phone Number

Santa Clara, California, United States

New Brunswick, New Jersey, US

• Handled and escalated non-conformances as needed to ensure timely resolution and continuous improvement.
• Conducted Design Failure Mode and Effects Analysis (DFMEA) to identify potential risks and implement mitigation strategies.
• Oversaw and managed TMVs to ensure that testing methods are reliable and valid.
• Conducted Gage Repeatability and Reproducibility (R&R) studies to evaluate measurement system variability.
• Performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate equipment and processes.
• Assisted in determining root causes of quality issues and develop corrective actions and recommendations to prevent recurrence.

Franklin Lakes, New Jersey, US

• Provided guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
• Supported new product design transfer activities and existing product sustaining activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively.
• Ensured adequate design control documentation and records are maintained to support life cycle of design history.
• Ensured the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
• Reviewed and authorized Quality approval for device design specifications including product performance specifications, test methods, acceptance criteria, and release.
• Supported product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data, and approving final reports.

Paris, France, FR

• Designed, developed, approved, and executed complex validation activities for pharmaceutical equipment and processes- to including “GMP on-location” execution, datapack compilation, data analysis, deviation resolution.
• Coordinated with internal resources to ensure appropriate project tracking and change control execution occurs.
• Executed IQ, OQ, and PQ tests on mixers, freezers, industrial refrigerators, fermenters, biocontainers, storage tanks, and Millipore Filters.
• Followed SOP guidelines to modify OQ tests on equipment that was never tested before. Utilized data loggers, RTD, and collection vials to execute different types of tests on freezers and refrigerators. Collected.
• Developed Change Control Requests for Pumps, Scales, Refrigerators, and Fermenters and submitted them in Phenix. Completed tasks such as tagging out equipment and tagging in equipment after CCR reaches the final stage.
• Constructed, developed, and implemented novel processes and procedures in a cGMP environment.

• Clients: EXP, Pinchin Environmental, BenEngineering, Flynn Canada, Sirati & Partners Consultants, GHD
• Collaborate with multi-functional teams in Research, QA/QC, Supply Chain, Maintenance, Manufacturing, and Regulatory Compliance to conduct quality audits and perform analytical testing of materials and process/product.
• Employ principles and concepts of Lean Six Sigma to improve process capability, perform process monitoring, assess product impact, and provide technical troubleshooting, using statistical process control (SPC) analysis.
• Develop product quality plans, documents, and systems by creating product specifications, quality specifications, and quality plans in conjunction with product development team members.
• Review, revise and approve documentation to validation/qualification of facilities, equipment, systems, and processes in compliance with requirements FDA CFR 21, ISO 13845, ISO 14971, CMDR, QSR, MDD, and cGMP.
• Track metrics to discover areas for improvement and monitor upgrades, conduct risk assessments, assemble reports to document process status and changes, communicate findings and proposals to upper management, and.

Toronto, Ontario, CA

• Collaborative position with Ryerson University and St. Michael's Hospital.
• Utilized Good Laboratory Practice (GLP) and GMP when conducting experiments, testing, handling of specification results, labeling solutions, data entry into Quality Tracker and maintain proper calibration/verification.
• With upstream and downstream process knowledge, monitor existing processes, ensuring that batch records are maintained, variances are investigated, and day to day activities are properly planned to activate and qualify.
• Expertise in support of analytical laboratory instrumentation and equipment qualification and calibration. Devise and implement methods and procedures for inspecting, testing mechanisms and equipment, and evaluating.
• Utilized ATRP controlled radical polymerization technique with electron transfer activator to produce polymethyl methacrylate in an emulsion medium used in bone cement fillers for dental / cast resins industries.
• An eco-friendly commercially available monomer was utilized with an initiator in an organic phase (MMA).Polymerization process was carried out in a stainless-steel reactor (PARR model), which was connected to a PID.