Ankush Patel Email & Phone Number

Philadelphia, Pennsylvania, United States

• Providing general or direct supervision to employees enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGXP through real-time verifications of records, logbooks, chromatograms, sequences, etc.• Managing day-to-day workflow, assigning work and monitoring processes to streamline the effectiveness of laboratory operations.• Helping analysts by troubleshooting methods, instrumentation, and execution of the tests.• Exercising judgment within defined procedures and policies to determine appropriate action.• Critically review data for anomalies or trends and approve data.• Assist or lead the investigation and preparation of Investigation reports.• Frequently interacts with subordinates, outside customers, other departments, and the QC management to improve efficiencies and processes within the laboratory.• Manage and monitor project progress and timelines to meet schedules.• Performed the actions mentioned in the section “Document Control Specialist”.• Performed any other duties as assigned by the QC management team.

Philadelphia, Pennsylvania, United States

• Preparation of new or revised documents such as Analytical procedures, specifications (Bulk, Finished, Stability, and Raw Material), etc.• Monitored the compendia such as USP-NF, FCC, and EP for the change of any procedure, test or any other change that affects the QC process.• Review of the master batch records as well as analytical data and logbooks.• Issuing the Certificate of Analysis or Certificate of Compliance.• Preparation of the Standard Operating Procedures (SOPs) and providing the training to related personnel.• Preparation of Method Validation Protocols and the reports. • Preparation of stability products protocol.• Preparation of the Instrument Qualification protocols. • Maintaining Calibration and Maintenance log for the QC Assets. • Initiate change control for the approval of the documents.• Equipment procurement, optimization, and troubleshooting of the process. • Contributed to team discussions and new project initiatives to advance progress and optimize profitability.

Philadelphia, Pennsylvania, United States

• Checked raw material documents for accuracy and compliance with requirements.• Performed standard and proprietary physical testing and chemical analysis of Raw Materials by using various instruments including but not limited to UV-visible spectrophotometer, HPLC, refractometer, IR spectrophotometer, etc.• Performed an analytical Method Validation as per regulatory guidance (ICH, FDA, USP, BP, EP, etc.)• Performed method transfer activity with various customers.• Evaluated the raw materials to assign grades and marked quality level, rejection status or acceptance.• Performed inventory control for the raw materials.• Maintained proper documentation of all activities.

Philadelphia, Pennsylvania, United States

• Tested products during and after production.• Interpreted and communicated results to supervisors, colleagues, sponsors, and customers.• Generated technical reports and other documentation to record analytical test results and conclusions.• Maintained proper documentation of technical and experimental activities.• Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.• Monitored consumable laboratory supplies and replenished inventory to enable timely completion of testing activities.• Reviewing of analytical data.• Collecting the samples of raw material and purified water.• Conducted all activities safely and efficiently.

Master Of Science, Biomedical Science

B. Pharmacy, Science