Ravi Kumar Email & Phone Number

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.
• 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.
• 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.

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.

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.

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.
• 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.
• Organize and lead meetings with team members to update and plan validation activities.