Nibhal Tamrakar Email & Phone Number

Carrollton, Texas, United States

Specialized in process validation, compliance audits, implementation of new measurement tools, development of SOPs, risk management, statistical analysis, equipment qualifications, regulatory and system validations as per GAMP guidelines.Responsible for quality engineering functions like process control, procedural compliance, deviation control, management, quarantine release oversight, internal/external auditing, change control, & CAPA processes.Collaborated with development teams to support pre-market activities related to risk management in compliance with ISO 14971, specifically focusing on wound dressing and bandages.Authored Risk Management Documents for the approval of products for Risk Management Plans.Supported remediation efforts for legacy wound dressing & bandages to meet current market demands.Assisted in preparing change requests to Risk Management SOPs, plans, and reports, documenting change details and ensuring thorough functional reviews and sign-off.Supported and drove updates to keep existing risk management documents up to date by incorporating information from post-production and field data.Utilized sources of data such as literature, post-market data, field complaints, and clinical trials to estimate harm outcomes of an identified new or existing hazard in the context of wound dressing & bandages.

Arab, Alabama, United States

Developed IQ/OQ/PQ protocols, conducted Gage R&R studies, and wrote reports for products and manufacturing equipment for process validation.Prepared cGMP process specifications and reviewed batch records.Performed legacy system remediation qualifications & validations on existing qualified process equipment for manufacturing according to 21 CFR Part 820 and ISO13485 guidelines.Executed equipment protocols (IQs, OQs & PQs) and revised SOPs for various types of legacy & new chemical lab and production equipment used in manufacturing Class II & III implantable medical devices.Generated and resolved protocol discrepancies or deviations, continually improved the Quality System Validation program, and participated in project planning, scheduling, and tracking.Prepared SOPs detailing validation policies, change control procedures, and equipment operation.Developed and maintained Control Plan and PFMEA documentation and procedures.

Birmingham, Alabama, United States

Generated & executed IQ/OQ protocols & reports during validation of testing equipment in the lab.Exposed to work orders, PM's, CAR's, SOP's, CAPA's, Change Controls & GMP for packaging area.Implemented Total Quality Management & Continuous Improvements programs designed to improve the quality of the product by trending supplier performance and by improving the packaging process.Assist packaging engineering department in packaging laboratory testing of new packaging concepts and validate new packaging designs through extensive testing protocols.Review, modify and audit executed protocols and Master Batch Records.Prepare protocol exceptions, process deviations and support investigations for NCs and CAPAs.Responsible for QA, R&D, Regulatory Affairs & Manufacturing groups assigned to process improvement, cost savings projects, new products introduction, CAPA’s and production operation. Translated Design inputs & Product Specifications into outputs through technical & design reviews.Worked as process and packaging engineer on products manufactured by Cordis, some of the products are Drug eluting Stents, Catheters, Balloon angioplasty, packaging configurations.Focus in daily support to operations, Problem Solving techniques, increasing OEE, process optimization, complaints investigations, process investigations, packaging development (material specifications, BOM's, pallet patterns, packaging orders), packaging assessments, and projects.Worked on Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability (DFM) to determine the accuracy and feasibility of manufacturing.

Birmingham, Alabama, United States

Prepared and executed material mechanical properties testing, test data correlation, process simulation, and test report documentation, facilitated informed decision-making and product validation.Helped in creating , reviewing, and annotating procedures following Good Documentation Practices (GDP).Performed CAD modeling (SolidWorks, AutoCAD), ensuring the product meets design specifications.Worked in fatigue and endurance analysis ensuring long-term durability and reliability of products.Supported engineering teams in maintenance and validation activities while learning about GMP standards.Prepared and executed material mechanical properties testing, test data correlation, process simulation, and test report documentation, facilitated informed decision-making and product validation.Collaborated with Quality Managers to support the development of a Quality Plan for monitoring the execution of remediation activities.