Vaishnavi Jiwade

Biomedical Engineer with practical experience in Quality Assurance, GMP documentation, QMS, CAPA, audits, and regulatory compliance. Seeking a challenging role in the Medical Device and Healthcare industry to apply my technical knowledge, quality systems expertise, and problem-solving skills while contributing to organizational growth.

Quality Assurance Apprentice - FDC Limited - Chhatrapati Sambhajinagar

(2025-05)

• Ensured compliance with GMP, GDP, and Quality Management System (QMS) requirements.
• Reviewed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for accuracy and compliance.
• Supported deviation investigation, CAPA implementation, and change control activities.
• Assisted in document control, SOP management, and quality documentation review.
• Participated in internal audits and quality compliance activities.
• Collaborated with cross-functional teams to maintain product quality and regulatory compliance.
• Performed data review and trend analysis to support continuous quality improvement.
• Gained hands-on experience in pharmaceutical quality assurance and manufacturing processes.
• Issued and controlled BMR, BPR, SOPs, and quality documents in compliance with GMP and QMS requirements.

Quality Intern - Ethicon (Johnson and Johnson MedTech)

• Supported GMP documentation review and quality compliance activities.
• Observed microbiological testing and quality control procedures.
• Gained exposure to production and warehouse packaging operations.
• Learned basics of Quality Management System (QMS) in medical device industry.
• Actively participated in 4 audits (BSI, JJRC, and internal DI/GDP audits), supporting audit planning, execution, and closure activities.
• Developed Understanding of documentation review including BMR/BPR, SOPs, and logbooks to ensure compliance with GMP and ISO 13485 standards.
• Gained understanding of non-conformance handling, root cause analysis, and CAPA procedures.

B.Tech - Biomedical Engineering - MGM University, Institute of Biosciences and technology (2022 - 2026)