Akhil Tummala Email & Phone Number

Raleigh, Nc, Us

Authored and Reviewed Process Validation Protocols, Process Media Fill Simulation Protocols, and Technical Studies for various drug products with different presentations (Abboject, Vial, Ampoule, and Syringe). Authored and Routed Pre-Execution Documentation (Pre-Restriction Notification, Restriction Placards, and Sample Labels). Created Sample Numbers for samples being utilized in validation execution testing in the Laboratory Management System.Drafted and Routed Process Validation Batch Records.Executed approved process validation protocols for formulation and filling of aseptically sterilized and terminally sterilized products with different presentations (Abboject, Vial, Ampoule, and Syringe). Authored Validation Deviation Reports and worked with Quality Engineers to determine root cause through the investigation and determine the corrective action. Reviewed and Redlined Process Validation Related SOPs.Performed Impact Assessments through collaboration with Quality Authority and SME for Process Validation Related SOPs.

South Bend, Indiana, United States

Wrote and implemented IOPQs, Cleaning Validation Protocols, and FMEA’s. Wrote Risk Assessments for Cleaning Validation and URS for Equipment Validation. Co-Managed the Cleaning Department and implemented SOPs for the cleaning and sanitization process for compounding and cleaning department. Implemented process improvement and assisted with internal audits and customer audits. Additionally, helped execute environmental monitoring in accordance to USP clean room standards.

United States

• Work with biomedical engineers on a regular basis.• Test and repair a wide variety of life saving biomedical equipment to ensure proper function.• Match equipment with its ancillary parts and consumables, and perform minor repairs as needed.

Bachelor'S Degree, Bioengineering And Biomedical Engineering

Activities and Societies: BMES Club

Biomedical Engineering

High School Diploma

Activities and Societies: PLTW Engineering(Processes of Engineering(POE), Civil Engineering and mechanical engineering classes) STEM Club.