Meghavi Patel Email and Phone Number

• Working collaboratively with Quality Assurance and Quality Control teams to improve processes and optimize productivity.• Supervise laboratory operations to maintain quality, efficiency, and turnaround time on lab work & Review and approve all microbiology test results, validation protocols and reports within assigned timelines.• Report, record, and lead investigations for any deviations from company procedures, or other discrepancies that may affect or indicate a microbiological problem with product quality; determine and implement any immediate corrective action as necessary; ensure the development of long-term corrective action including identifying root causes; facilitate and review final implementation of corrective action plans.• Provide support for implementation of new instruments or processes.• Review and develop current and future laboratory operations and SOPs to improve efficiency and productivity.• Lead by example our team members who are responsible for the day-to-day activities in the Micro lab.• Ensure that applicable equipment/instruments in the microbiology laboratory are qualified, maintained, and calibrated and that system suitability is properly verified. Review and approve as required Microbiology equipment IQ/OQ/PQ protocols and reports.• Ensure that the Micro team is aware of and following work instructions, safety protocols, and daily schedules.• Review, initiate and approve, as required, changes to assure continuous improvement of microbiology procedures (test methods, training modules, system SOPs)• Ensure that the Microbiology laboratory facilities and operations comply with safety and environmental regulations, including chemical and microorganism handling and disposal of laboratory waste and compliance to Canopy Standard Operating Procedures (SOP’s)• Adhere to appropriate quality measures, which meet or exceed the standards set by government regulation and company requirements.

• QM Software SAP S/4 Hana Cloud experience, Trellis System, Bio-Track System, Intelex – QMS Management (Document Control, Inspection Management, Non-Conformance Reporting, Quality Comply, Root Cause Analysis RCA, Corrective Preventative Action CAPA, Defect Codes, Sampling Plan, Maintenance Request).• Monitor the Environmental, water, chemical, product and Fertigation parameters by sampling and providing analytical testing in the facility.• Conduct chemical, environmental and microbiological tests and analyses as required.• Performed analytical instruments activities related to chemical/Biochemical/product parameters and sampling including the instrument/equipment’s routine verification, maintenance, operational checks and calibration as required.• Developed new procedures, revised procedures, redacted procedures, performed routine Inspection, Audits, Root Cause Analysis (RCA), Corrective Actions, Preventative actions, Proactive Measurements and Nonconformance Reporting (NCR) / Deviation Reporting.• Worked on project for introducing new Quality Assurance and Control (QA) testing and analyzing procedures that includes sampling, stock preparation, dilution, calibration, statistical analysis and report preparation. • Experience in computer programs for analyses and data interpreting on computer-based laboratory equipment.• Verify and entry of all product data/inventory (historical, current) into the database system• Maintain accurate records of all analysis including QA/QC requirements that ensures high quality and accurate data of the product and intermediate products.• Upon completion of necessary training, coordinate crew tasks and interface with workgroups outside of Chemistry, especially Operations.• Material Acquisition Request Approval process• Provide QA training to other departments• Compile lot release packages and audit documentation for lot release• Work closely with the departmental managers to ensure staff are working in compliance

• Calculated, prepared and filled drug orders according to all prescription details • Properly maintained all legal records and drug logs using heightened accuracy and attention to detail• Monitored and maintained adequate drug inventory levels by placing orders and restocking as needed • Provided assistance to customers with telephone and in person inquiries using strong communication and interpersonal skills

• Created Standard Operating Procedure for API (Active Product Ingredient) and set up Lab standards and trained the employees.• Collected and tested sample batches, analysis done by GC, HPLC, UV Spectrophotometry, paper chromatography, recorded data, interpreted pictograms/statistical analysis and reported results with accuracy using laboratory instrument system software.• Prepare chemical solutions and its standards/stocks, and other laboratory reagents as required to maintain chemical testing requirements as per SOP of the laboratory.• Monitor all laboratory’s analytical equipment by periodical verification, operational inspections and calibration as required.• Performed Root Cause Analysis, Deviation Reporting and Corrective actions.• Obtained and analyzed swabs for bacterial contamination or chemical residue to confirm sanitation of Quality Control Laboratory in a fast-paced environment• Communicated with production staff to change and improve procedures where necessary• Part of the maintenance and updating of the Hazard Analysis Critical Control Point