Pranjal Shibe

Bioanalytical Sciences postgraduate with professional experience in Pharmaceutical Quality Assurance. Skilled in Quality Management Systems (QMS), GMP documentation. Experienced in handling QA QMS, SOP management, supporting USFDA and local FDA audits. Strong understanding of GMP, GLP, GDP, and pharmaceutical quality systems with excellent documentation and compliance management skills.

QA Officer at ASolution Pharmaceuticals Pvt. Ltd. (2026-01 – Present)

• Initiate and manage Quality Management System (QMS) activities for the QA department
• Track and maintain QMS records manually and through Microsoft Excel
• Issue and control GMP documents including BMR, BPR, AWR, ECR, SOPs, and other QA-related documentation
• Update and revise Standard Operating Procedures (SOPs) in compliance cGMP
• Perform impact assessments and assist in closure activities for Change Controls, CAPA.
• Initiate customer complaints and assist in root cause investigations and corrective action implementation
• Prepare audit compliance documentation, departmental schedules, and quality records
• Support vendor qualification activities by completing customer vendor questionnaires
• Assisted during unannounced USFDA audit and local FDA audit in February 2026;

QA Trainee at ASolution Pharmaceuticals Pvt. Ltd (2025-07 – 2025-12)

• Prepared Annual Product Quality Review (APQR) documentation for manufactured APIs
• Assisted in tracking and maintaining QMS-generated records and documentation
• Supported routine QA documentation and compliance activities
• Assisted in maintaining documentation in accordance with GMP

Master of Science in Bioanalytical Sciences – Ramnarain Ruia Autonomous College, Matunga (2023 – 2025)

Bachelor of Science in Bioanalytical Sciences – Ramnarain Ruia Autonomous College, Matunga (2020 – 2023)