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.
• 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.

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.

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.
• 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.

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.

Master Of Science, Biomedical Science

B. Pharmacy, Science