Ankith Kumar Email & Phone Number

Waco, TX

• Expertise in Preparation of high-level documents and protocols like Process Validation, equipment Validation, cleaning and sterilization validation, Master Validation Protocols related to Facility and process related.
• Drafted and Executed Site Acceptance Test (SAT), Installation and operational qualification (IOQ) and performance qualification (PQ) for Semi-Automated Unit Dose Packing Line.
• Handled the Quality Management system (QMS)
• Preparation and Review of Master and Executed BMR’s, PDR’s, Tech transfer documents, SOPs and other quality related documents
• Authored Qualification Protocol’s and Performed IQ, OQ, PQ of Equipment’s like Fermenters, Process vessels, Kill tanks and Temperature mapping Study Studies.
• Aseptic process simulation study protocol and report preparation.

Gaithersburg, MD

• Responsible for Quality and Validation Activities at CMO site for scale-up and commercial manufacture of Pharmaceutical products.
• Troubleshooting, Commissioning and Qualification of a new manufacturing facility and manufacturing and packaging equipment.
• Involved in performing Root Cause Analysis as part of CAPA.
• Developed CAPA plans for events identified during gap assessments.
• Involved in Effectiveness monitoring of CAPA’s.
• Assisted in the review and application of GAMP 5 requirements to the Commissioning and Qualification Validation project plan.

Lexington, MA

• Authored High Level Documents related to Validation activity, like URS, FAT, SAT, IQ/OQ/PQ of Key Process Related Equipment and analytical lab instruments.
• Responsible for writing, analyzing and reviewing validation deliverables like Validation Plan, Functional requirement Specification, System Design Specification document.
• Authored and reviewed cleaning and sterilization validation protocols, validation master plans, technical memos, protocol addendums and assessments, for production equipment and processes.
• Authored Validation Summary Reports for executed Cleaning and Sterilization Validation runs, Area related Qualification Activity, and Memorandums for executed Engineering runs and taking approval of quality units to.
• Involved in visual inspections for cleaning validation of varies process related Equipment’s, Blenders, Process tanks, facility and utilities.
• Performed Temperature mapping of Cold Rooms, Incubators and Deep freezers.

Hyderabad Area, India

• Performed User and Business Requirements analysis to prepare Validation Master Plan.
• Established operating requirements and conducted tests to assure it is operating under normal and worst case.
• Performed Positive and Negative Testing of the application.
• Written IQs, OQs, PQs and documented results in compliance with FDA regulations.
• Performed GAP Analysis and developed Remediation Plans.
• Performed System testing and documented results as part of IQs, OQs and PQs.

Bachelor Of Technology - Btech, Mechanical Engineering

Master'S Degree, Industrial Engineering