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 equipment and Hold time studies of Equipment’s (DEHT, CEHT & SHT). • 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.• Participated in qualification/validation/remediation of various analytical laboratory instruments and associated computer systems as per 21 CFR part 11/Annex 11/cGLP regulations. • Performed trend on CAPA quarterly to draw a summary and conclusion to understand the weak systems to be focused, repeated failures even after implementation of CAPA identified which ensures to implement the system effectively.• Ensured effective root-cause analysis (RCA) has been conducted during the initiation of CAPA.• Participated as a CAPA coordinator which involves in log, review, providing due dates and closure.

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.• Developed Validation Master Plan, Facility Validation Plan, and Cleaning Validation Master Plan & IQ, OQ & PQ templates.• Developed IQ/OQ/PQ templates for equipment, and processes – Cleaning Process Validation and Sterilizations.• Performed Change Control using Trackwise (COTS) with process template for Commissioning, Qualification & Validation (CQ&V) project.• Developed User Requirements and Design Qualification templates and training material for cGMP critical systems.• Risk Assessment – Facility, Systems, and Process Quality Project Plan (QPP) and initiation of System Impact Assessment (SIA) and Critical and non-Critical Assessment (CA) for project plan.• Developed Cleaning Mechanisms and Strategies, plus mixing studies, CIP/COP Cleaning Program Sequences for Pipes and Vessels. Revised Cleaning Validation Master Plan.• Developed and executed IQ, OQ & PV for Aseptic processing, buffer tanks, preparation & pressure vessels, mixing, heating & cooling tanks, storage & transportation vessels and their cleaning validation and Aseptic Fill and Monitoring systems, plus clean room air flow, steam generators.• Developed Cleaning Program and Protocols for Vessels and Piping. (CIP, COP and Manual Systems) and experience in temperature mapping using kaye validator. • Developed SOP, for the filing lines and Packaging Lines and concurrent with cGMP requirements.

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 ensure GMP compliance.• 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.• Experience in validation of analytical instruments like Chromatography Systems, Spectrophotometers, wet lab instruments and other microbiology lab instruments and associated computer systems.

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.• Updated and Maintained Required Traceability Matrix (RTM) as per the changing requirements.• Developed Validation Summary Report (VSR).• Ensured validation documentation for compliance with cGxP.• Using backward/forward tracing of requirements and finding source using Requirement Traceability Matrix (RTM) for the application.• Involved in validation of Laboratory LIMS, Manufacturing Automation Systems, TrackWise, ERP Systems. • Wrote SOPs for training manual, storage and maintenance to comply with 21 CFR Part 11 and GLP requirements.• Developed Test plan and written several test scripts for validation testing.• Reviewed and Documented IQ/OQ/PQ protocols.• Developed Test Cases and Test Scripts to perform regression testing using Win Runner.

Bachelor Of Technology - Btech, Mechanical Engineering

Master'S Degree, Industrial Engineering