SONALI PATEL

• Created and maintained a database of all records related to the QMS.
• Suggested hypothesis study for laboratory events like out of specification results, Out of trend results and laboratory incidents and performed detailed investigation to identify root cause.
• Prepared investigation report based on investigation outcomes as per SOP, regulatory, and GMP requirements.
• Having good experience in how to use investigation tools like 5 WHY, Fishbone diagram, Pareto chart, DMAIC template, and brainstorming.
• Ensure proper documentation was maintained throughout all stage of quality control process.
• Prepared a presentation on quality control activities, including findings, recommendations, and corrective action plans.
• Coordinated with a cross-functional team to deliver high-quality results within timelines.

• Performed analysis of raw material, in-process sample, finished good, and stability sample as per standard operating procedure and pharmacopoeia.
• Reported results and submitted data into LIMS.
• Monitored and recorded environmental conditions inside the facility that may affect product quality, such as temperature and humidity.
• Qualification of working standards performed and preparation of individual vials for usage with proper labeling.

Production assistance (2020-2021):

• Maintained the manufacturing area clean and in accordance with CGMP requirements.
• Prepared documents for the production department and issued documents for the batch from the QA department.
• Maintained all records for documents, and prepared a master list of products and manufacturing equipment.
• Prepared dispatching material label, and ensured packaging and storage conditions.
• Tested product samples for specific gravity, chemical characteristics, pH levels, concentrations and viscosities.
• Monitored packaging and storage of hazardous materials and waste to comply with laboratory, state and federal safety regulations.
• Organized, analyzed and prepared data research reports in compliance with operations and record-keeping standards.