Mohan Venkata Padala

Continuous value addition to excel in the chosen field & thrive for the betterment of my organization, my society & myself to become a part of winning team which invents path to create future & Provides paths to others.

A Competent professional with over 09+ years of experience in Computer System validation (CSV), Process Engineering, Digital Manufacturing and Manufacturing Operations in pharmaceutical Industry.

• Executed validation activities for computerized systems in accordance with regulatory requirements such as FDA 21 CFR Part 11, GAMP 5, and EU Annex 11.
• Developed and executed validation protocols including IQ, OQ, and PQ, ensuring the reliability and accuracy of systems critical to pharmaceutical operations.
• Actively participated in continuous improvement initiatives, identifying opportunities to streamline validation processes and enhance system efficiency.
• Managed documentation control processes, including document creation, review,approval,distribution & archival to ensure accuracy & accessibility of quality records.
• Faced USFDA, ANVISA, TGA, and EU Audits for the commercialization of the plant.
• Collaborating with site Automation team to streamline the integrations related to the equipment Automation.
• Handling incident Investigations and working with the vendor on major issues.
• Analyzing the Breakdowns for various failure modes effects & causes and propose & adhere to Corrective Action & Preventive action.
• Monitoring and Execution of Aseptic Filling activities and its related online documentation through EBMR’s & Log books.
• Monitoring and Execution of production Activities in Filling Areas in accordance with CGMP requirements.

I hereby declare that the above provided information is true to the best of my knowledge.

                                                                                                                                         Regards,

                                                                                                                            Mohan Venkata Padala.