Bharvi Gandhi

• Performed routine analysis of raw materials, intermediates, and finished products following written standard test procedures and official compendia, ensuring compliance with cGMP, environmental, and safety regulations. Provided support to Quality Control (QC) and Analytical Research and Development (ARD) activities at USPharma Ltd.
• Operated, calibrated, and maintained various instruments, including HPLC, USP Dissolution Apparatus (3), Karl Fischer titration, pH meter, and analytical balances using Standard test procedure and standard operating procedure.
• Performed and reviewed assay, impurities, and dissolution testing, analyzing the data using HPLC with OpenLab software for commercial validation and stability batches.
• Ordered and maintained laboratory supplies.
• Gained knowledge regarding stability sample pull and its maintenance.
• Created and updated Quality control documents, validation protocols.
• Gained knowledge and hands-on experience in method validation for assay testing, performing and analyzing various parameters such as linearity, accuracy, precision, specificity, and the stability of standards and samples.
• Prepared analytical test forms for in-process and finished products, and generated certificates of analysis and stability summaries for release.

Analytical Research and Development:-

• Performed daily calibration on analytical balance and pH meters as per standard operating procedures.
• Support stability study with sample analysis and evaluation.
• Conducted dissolution studies on various dosage forms, including tablets and capsules, while acquiring expertise in analyzing and processing data.
• Prepared and analyzed samples for assay and related compounds using HPLC (Waters and Shimadzu systems) with Empower software.

Quality Assurance Department:-

• Gained experience in writing and managing Standard Operating Procedures (SOPs). Conducted internal audits to ensure compliance with regulatory standards and quality management systems.

• Responsible for ordering, receiving, and maintaining the inventory of medications and pharmaceutical supplies.
• Accurately dispensed medications to patients based on prescribed orders.

Internship Traning:-

• Obtained detailed knowledge about the typical workflow of the pharmaceutical industry and its SOPs with all the regulatory compliances.
• Familiarized with the quality control, quality assurance, manufacturing, production, and packaging departments and their responsibilities.