Sonali Patel

Five years of experience in pharmaceutical industry in Quality control and quality assurance, production and validation department. Resourceful validation officer for high productivity and efficient task completion. Specialize in machinery operation, quality control, and safety protocol adherence. Excel in problem-solving, teamwork, and adaptability to rapidly changing production environments. Committed to maintaining high standards of workmanship and contributing positively to team goals.

Validation officer at Biomed pharmaceutical Limited

• Preparation of protocol for routine validation and performing routine validation.
• Preparation of routine validation report and reference supporting data.
• Planning of master validation plan and other ongoing non routine instruments installation projects.
• SOP revision and CAPA implementation.
• Installation and operational qualification protocol drafting.
• Coordination with cross functional group for planning of validation.

Production Technician at Biomed Pharmaceutical Limited

• Ensured compliance with safety regulations to uphold a clean, safe work environment.
• Monitored adherence to safety standards during manufacturing per CGMP and Batch Manufacturing Order.
• Performed daily cleaning of clean room and conducted thorough pre-use inspections.
• Set up and operated production equipment according to daily work orders and safety protocols.
• Collected materials from storage based on bill of materials while ensuring quality standards.
• Returned all raw materials to storage for reconciliation after completing batch production.
• Planned work assignments by analyzing worker performance, machine capacity, and potential delays.

QA-QC Executive at Alembic pharmaceutical Limited (2023-05 – 2024-06)

• Collaborated with cross-functional teams to resolve quality-related issues swiftly.
• Conducted laboratory investigations for incidents, out-of-specification results, and out-of-trend results.
• Developed hypothesis study protocols to identify root causes of lab events.
• Utilized 6M Methodology, 5 WHY analysis, Fishbone diagram, and brainstorming tools for thorough investigations.
• Compiled detailed investigation reports outlining root causes and recommended CAPA to prevent recurrence.
• Tracked records for CAPA activities and prepared closure reports accordingly.
• Created presentations for weekly and monthly meetings to communicate findings.
• Summarized data for out-of-specification, out-of-trend results, and lab incidents.

QC Analyst at Century Pharmaceutical Limited (2020-10 – 2023-04)

• Performed all tasks in the laboratory as per GMP and SOP very accurately and within the deadline.
• Receive all samples for testing from the manufacturing and vendor sites, record all entries, and keep documents updated.
• Performed analysis of raw materials, in-process samples, finished goods, and stability study samples as per the method of analysis, and recorded all performed results in the protocol, and prepared results while maintaining all documents.
• Qualification of working standards and maintained reconciliation and stock take records up to date.
• Preparation of documentation, such as the method of analysis, specifications, and SOP, as per guidelines, regulatory requirements, and in accordance with audit compliance and vendor requirements.
• Performed change control activity for any lab-related changes, such as permanent or temporary changes, and discussed them with cross-functional groups.
• Performed daily verification of lab instruments, and kept them clean. Monthly calibration of lab instruments was performed, and data was kept for reference and approval; the QA instrument calibration log was updated.

Master of Science in Organic Chemistry – Sardar Patel University (2020-08)

Bachelor of Science in Chemistry – Sardar Patel University (2018-06)