Regulatory Affairs Quality Assurance

ZEEL SHAH

+1-857-***-**** ****.**@************.*** www.linkedin.com/in/zeelshah2502

EDUCATION

Northeastern University, College of Professional Studies Boston, MA Master of Science in Regulatory Affairs (GPA-3.9) April 2025 Nirma University, Institute of Pharmacy Ahmedabad, IND Bachelor of Pharmacy (GPA-3.4) June 2022

WORK EXPERIENCE

TScan Therapeutics Jan 2024 - Sept 2024

Quality Assurance Co-op

• Verified and inspected Raw materials and Leukopaks, ensuring compliance with GxP regulations, and proper storage conditions.

• Led a document digitization project, and ensured audit-ready documentation in compliance with FDA 21 CFR Part 11 while performing quantitative and qualitative analysis of drug products for defects.

• Managed document control through Veeva Vault QMS, supported internal audits, recommended corrective actions to ensure GMP, FDA compliance and investigated 10 deviations, implementing CAPA to reduce nonconformances by 30%.

• Assisted in pre-batch inspection activities, including verifying line clearance, reviewing staged materials and batch-related documentation, inspecting initial units, and approving line release.

• Developed detailed SOP workflows for critical QA processes, including raw material receipt, batch records, change control, and deviation management, ensuring regulatory compliance with FDA GMP (21 CFR Parts 210/211, 820) and ISO 9001 standards. Supravitz Life Sciences Jun 2021 - Nov 2021

Regulatory Affairs Intern

• Supported label reviews for dietary supplements to verify compliance with FDA 21 CFR Part 101 and global labeling regulations.

• Reviewed and helped in compiling technical documentation (eCTD) for product quality to support regulatory submissions.

• Develop a Hazard Analysis and Critical Control Points (HACCP) plan to identify and control food safety hazards.

• Ensured SOPs were audit-ready, maintaining compliance with regulatory requirements such as FSSAI, WHO-GMP, and ISO 22000.

• Assisted in the collection, evaluation, and reporting of post-market data to regulatory authorities as required (e.g., adverse event reporting, recalls, safety notices).

ACADEMIC PROJECTS

FDA Warning Letter- Solutions & Design Control Plan

• Analyzed FDA Warning letter and came up with corrective and preventive action plans to resolve the issues.

• Drafted solutions for non-compliance and design control development of Mini-Med 600 series insulin pumps, medical devices. Design Control Project

• Developed a Design Control & Development Plan for a Class II medical device, aligning with FDA 21 CFR 820, ISO 13485, and 510(k) submission requirements.

• Implemented risk management strategies (ISO 14971), created a Design History File (DHF), and established design verification & validation (IQ, OQ, PQ) protocols.

FDA QSR Compliance Analysis & CAPA Implementation

• Reviewed 3 FDA QSR Warning Letters to identify compliance gaps in CAPA, Design Controls, and Production & Process Controls.

• Developed Corrective & Preventive Action (CAPA) Plans, including root cause analysis, process improvements, and internal audits.

• Implemented risk-based strategies and training programs to prevent recurrence and ensure QMS compliance with 21 CFR Part 820. Development of QSR-Compliant SOPs for Medical Device Manufacturing

• Authored Three QSR-Compliant SOPs aligned with FDA 21 CFR Part 820 and ISO 13485 to ensure regulatory compliance in medical device manufacturing.

• Developed SOPs for Key QMS Subparts, covering Corrective and Preventive Actions (CAPA), Production & Process Controls, and Nonconformance Management with structured procedures, roles, and responsibilities. SKILLS

Quality: 21 CFR Part 11, Part 820, Part 211, Root Cause Analysis - Fish-bone diagram, 5 Whys, Risk Management - FMEA, Quality Management System, CLIA Requirements, Electronic Common Technical Document (eCTD), Training and Vendor management Software: Microsoft Office (Word, Excel, PowerPoint), Veeva Vault QMS, Greenlight Guru, Master Control Analytical: Liquid Chromatography, Titrimetric Analysis, Electrophoresis, Spectrometry, ELISA

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