Dhruv Patel Email & Phone Number

Markham, Ontario, Canada

• Provide independent QA oversight for Quality Assurance activities in compliance with GMPs, GDP and Teva Canada's SOPs. • Interim decisions on any quality deviations related to manufacturing operations. Communicate and interact directly with various department to resolve quality issues and avoid delays impacting production activities. • Review and Audit manufacturing/packaging documentation and release of bulk/finished products in as close to real time as possible ensuring GMP and SOP compliance including electronic data review in SAP and MES system. • Prepare accurate, clear and logical audit notices and maintain audit metrics. • Provide quality oversight and support in the evaluation of quality floor incidents such as Deviation Investigation Form (DIF), review and approval of Work Orders, PSS comments, review of change controls, electronic data review and performing trend analysis for walkabouts and work orders. • Perform documentation audits/reviews and internal plant GMP audits such as logbook auditing, BAS acknowledgement comments, Work Orders and evaluations. • Perform AQL evaluations including issuance, verification and evaluation and assist in the sampling and tagging of packaging material, bulk or finished products when required. • Support in minor deviations, complaints, CAPA's, CAPA ERs as and when needed. • Performed QA-related Corrective Action and Preventative Actions, GAP Assessment against Global and Regulatory procedures and evaluate the effectiveness of the implemented CAPAs. • Lead continuous quality improvement plans. • Collaborate with manufacturing, validation, QC and TS to provide QA insight for on-going/new projects/incidents. • Schedule and participate in internal quality audits and management walkabout program. • Assist and Participate in external regulatory audits as and when required. • Applicable knowledge and usage of software tools like SAP/MES, Trackwise and LIMS.

Toronto, Ontario, Canada

• Accurately performing duties in accordance with SOP, GMPs, MBR, Health & Safety procedures, Equipment Manuals Job Aids and Working instructions. • Accurately performing all GMP documentation in their area of responsibility. • Dismantles, cleans, assembles, and set-up processing equipment according to Equipment Manuals, Working Instructions and Job Aids. • Ensuring the proper selection, care and use of tools, parts and equipment.• Preparing and completes the necessary documents, including labels, logbooks and require department documents.• Arrange and store materials in appropriate designated areas of facility as per the department standard procedure. • Operates the tableting equipment and identify issues in a timely manner and escalates to senior for resolution.• Accurately performs ERP data entry and transactions as required. • Set up Coating Machine for run, including preparation of solution for coating operation as per Production Batch Record. • Maintain Coating Machine in good working condition, inspect the machine for wear and tear and report any malfunctioning parts to seniors for resolution. • Visually inspect Coating machine and mixers as it is running to verify the machine is running within normal and safe operation. • Performing in process physical measurements of tablets throughout the coating run and documents these measurements in Production Batch Record. • Performing cleaning and disassembling Coating machine and its parts, containers, mixers, room after the completion of coating operation as per MBR and SOP. • Document all set up and cleaning in the log book and other pertinent paperwork.

Toronto, Ontario, Canada

• Demonstrated excellent customer service in a friendly and professional manner while upholding great customer relationships throughout the local community.• Capable of successfully communicating and coordinating with a diverse range of business professionals and consumers.• Entrusted key holder responsible for ensuring execution of standard procedures while opening and closing daily operations.

Ahmedabad, Gujarat, India

• Operated laboratory equipment and computers, and performed chemical analyses in accordance with documented laboratory procedures.• Performed procedures and calculations crucial to quality control including pH testing, instrument calibration, centrifugation, dissolution, UV/Visible spectrophotometer, and high-performance liquid chromatography (HPLC).• Performed quality control tests using electronic balances, scales, sonicators, and titrations in accordance with established procedures.• Conduct routine and non-routine analyses of in-process materials, samples, and finished products.• Documented and compiled all observations and data obtained from testing as per the established SOPs and good documentation practices ensuring compliance with regulatory and safety requirements along with GLP standards.

Ahmedabad, Gujarat, India

• Worked closely with the QC SOP development team to continuously improve all procedures and quality standards.• Created quality measurement metrics to accurately and consistently measure improvements in the product and communicate improvements to senior associates.• Executed quality improvement testing and other activities and generated reports to be used in data analysis.

High School Diploma, Biotechnology, 85%

Bachelor'S Degree, Pharmacy, 82%