Ravi Kumar Email & Phone Number

United States

Washington, United States

• Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Assembles and composes the final report and circulates for approval.• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation.• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.). • Develops/improves validation programs as needed to remain current with GMPs and industry standards.• Leading and managing different sub contractors to achieve the correct installation of dirty and clean utilities, which include:- Verification of the correct installation and operation of various Air Handling Units for clean roomoperations- Working with Siemens and Mangan contractors on the installation and commissioning of theBuilding Automation System for various utilities like instrument air, nitrogen, water, steam and glycol.- Redlined existing Piping and Instrumentation diagrams to reflect the existing operations using Bluebeam.- Managed existing and future tasks for different sub contractors using EIDA paperless engineering system

Rocky Mount, North Carolina, United States

• Worked on Oracle Pedigree & Serialization Manager (OPSM) is used to generate unique serials for all medical devices.• Developed and executed protocols for package design, packaging processes validation, and package shelf-life testing. Reviewed the Design History Files (DI-IF). Hands-on experience in DFMEA and PFMEA Analysis.• Developed Operation Qualification (OQ) test scripts for Track Wise Change Management modules andCAPA system• Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820• Workflows implemented included complaints, CAPA, and Change Control• Reviewed and approved the SOPs documented for the validation protocols.• Reviewed Validation Master Plan (VMP) and Validation Protocols (IQs, OQs, and PQs) in detail. Wrote test scripts & deliverables for validating Documentation.• Strong documentation skills for writing and executing verifications per FDA regulatory requirements and under a Quality System design control process and procedure.• Reviewed test cases and scripts and documented the results as per the FDA regulations.• Involved in preparing compliance reports about the existing status of the cGMP, GCP, and GLP.• Involved in preparing documentation for all aspects of the computer system validation lifecycle in accordance with FDA regulations, particularly System Requirement Specification (SRS) and Performance Qualification (PQ) Specification.• Remediated Design Verification and Validation inconsistencies of the Design changes.• Implemented Design History File (DHF) Remediation using Design Control elements as per 21 CFR 820Regulations on disposable medical devices• Understanding of FDA guidelines, ICH Q7, Q8, Q9, QIO and other international regulatory requirements.• Responsible for approval of design verification, Validation plan, protocols and completion report for multiple projects.

Milpitas, California, United States

• Action and Preventive Action (CAPA).Loaded IQ, OP, PQ, TMV documents into PDM system for review and approval signatures.• Created validation products including Validation Scripts, Toolkits, Documentation, and Services.• Hands-on experience in cleaning validation of various commercial solid dosage form equipment.• Monitored processes governing tests like Bowie Dick test, Steam Penetration Test, ensuring precision and compliance.• Trained operators to improve energy conservation efforts, resulting in reduced utility bills and downtime.• Documented testing conducted by the QA department and served as a Validation Subject Matter Expert.• Prepared detailed SOPs for IQ and PQ and executed CSV activities for Clean-In-Place systems and automated purified water distribution systems.• Reviewed and identified gaps in TMV protocols and reports for remediation/revalidation.• Documented all materials during the testing phase and created SDLC/UAT/Business Procedural documentation for reporting.• Working with the validation team leader, created the customer specific Equipment Installation andOperational Qualification Protocol (IOQ) standardized template, along with the templates for the Process Operational Qualification Protocol (OQ) and the Performance Qualification Protocol (PQ), intended for Phase l, Il, Clinical Trials, and Phase Ill of the Pilot Program development process.• Ensured adherence by staff to quality, regulatory,• Involved in all phases of SDI-C according to Company procedures, FDA Guidelines, GMP.• Evaluated design and processes to determine suitability for manufacturing, followed by R&R analyses.• Performed V & V for all approved product contacted areas and product/process materials used.• Created documents such as PFMEA, MVP, TMV, IQ, OQ, PQ etc.• Authored and Executed IOQ, OQ, AND PQ protocols for various automated assembly systems and on-line inspection and test systems, including software and/or firmware/hardware and PLC systems.

Hyderabad, Telangana, India

• Develop software validation plans to determine the planned validation activities, deliverables, responsibilities and approval authorities for all computer system validation activities throughout the life cycle of the system.• Determine user requirements to describe the required functions and capabilities derived from the users’ and overall business needs.• Develop functional specifications to specify how user requirements are to be accomplished by defining the detailed functionality of system modules and sub-processes that carry out the previously documented requirements.• Collaborate with senior technicians in the Production floor and Labs to transfer knowledge of the active products and processes.• Participate in risk analysis using FMEA tools to determine what risks may impact the correct or reliable functioning of the computer-related system. This document is an FMEA (Failure Modes Effect Analysis). Develop and implement risk mitigation measures as required.• Organize and lead meetings with team members to update and plan validation activities.• Document and execute software installation qualification (IQ) to establish documented evidence that a system has been installed and configured per the approved design specification document(s).• Document and execute software operation qualification (OQ) to provide documented evidence that the software and associated computer-related systems conform to user needs for their intended functions.• Document and execute software performance qualification (PQ) to establish that the new or modified computer-related system processes, as defined in the user requirements, are effective and reproducible in a normal business environment.• Create Validation Summary Report to summarize the qualification procedures and ensure that the software produces the expected and reproducible results.• Support the qualification of new software suppliers to include the performance of software supplier audits.