Shani Patel

Quality Assurance & Validation Specialist with 3 years of experience in GMP-regulated pharmaceutical and life sciences environments. Proven expertise in IQ/OQ/PQ validation, batch record review, deviation investigation, CAPA management, change control, stability studies, and regulatory audit readiness. Strong track record of ensuring compliance with FDA 21 CFR Part 11, GMP, ISO 13485, and ALCOA+ data integrity principles.

Adept at collaborating with QA, QC, Production, and Engineering teams to maintain inspection readiness, improve quality systems, and deliver consistent product quality in highly regulated operations.

Quality Assurance Intern - Amgen - USA

(2025-05 - 2025-12)

• Ensured end-to-end compliance with GMP, SOPs, and regulatory guidelines in a highly regulated pharmaceutical manufacturing environment.
• Performed detailed batch record review (BMR/BPR) to verify accuracy, completeness, and data integrity prior to product release.
• Collaborated cross-functionally with Production, QC, and Engineering teams to resolve quality issues and improve process efficiency.
• Reviewed logbooks, cleaning records, and equipment usage reports to confirm proper documentation practices across GMP departments.
• Managed and tracked CAPA implementation, ensuring timely closure and continuous quality improvement.
• Assessed completeness of sampling records and supported the release of materials by coordinating with QC testing timelines.
• Identified recurring documentation errors and proposed practical steps, improving compliance behavior on the shop floor.

Quality Assurance Specialist - Zydus Lifesciences - Ahmedabad, India

(2023-01 - 2023-12)

• Executed routine and non-routine quality checks on development batches, helping R&D teams verify product performance before scale-up.
• Assisted in preparing qualification-ready documents for laboratory instruments, ensuring accuracy and compliance in analytical operations.
• Evaluated sample results against predefined specifications and reported potential concerns to senior QA staff for further investigation.
• Contributed to the harmonization of laboratory test procedures, improving consistency in analytical practices across the R&D unit.
• Supported preparation of stability-related QA documentation, enabling accurate tracking of product behavior under various environmental conditions.
• Verified completeness of experiment records and ensured traceability of data as per ALCOA+ requirements.
• Participated in risk evaluation discussions for test method changes, helping reduce testing variability across batches.

QA Intern - Zydus Lifesciences - Ahmedabad, India

(2022-06 - 2022-12)

• Observed and documented step-by-step laboratory testing workflows, ensuring alignment with QA oversight practices.
• Performed preliminary checks on raw material documentation to confirm supplier compliance before QC review.
• Helped maintain sample logbooks and labeling accuracy, improving traceability and preventing mix-ups.
• Supported QA staff during line-clearance and pre-operation verification activities, gaining experience in floor-level quality checkpoints and understanding how manufacturing readiness is confirmed before batch execution.
• Participated in internal discussions on improving data recording consistency within R&D documentation.
• Collaborated with senior QA analysts to understand deviation workflows, learning how issues are logged, categorized, investigated, and resolved through structured root-cause analysis and documentation practices.

MS - Regulatory Affairs - Drugs, Medical Devices & Biologics - Northeastern University (2025-12)