Sarfaraz Mansuri

A highly motivated and detail-oriented Validation Engineer with a strong foundation in validation processes and compliance with regulatory standards. Proficient in Computer System Validation (CSV) with a thorough understanding of GAMP5 guidelines and 21 CFR Part 11 compliance requirements. Skilled in creating, reviewing, and executing validation protocols, including IQ, OQ, and PQ, to ensure the reliability and integrity of computerized systems in regulated environments.

Experienced in conducting risk assessments and preparing validation documentation. Adept at collaborating with cross-functional teams to streamline validation processes and maintain regulatory compliance.

Jr.

Validation

Engineer - Spark GxP Systems LLP - Ahmedabad

(2024-08)

• Development and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Designing protocol test cases to verify system functionality, performance, and compliance with user requirements, specifications, and regulatory standards.
• Defining validation deliverables, including validation plan, protocols, test scripts, and validation reports for qualification activities.
• Proficient in creating CSV deliverables like System Requirement Specifications (SRS), Functional Risk Assessment (FRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).
• Prepared and executed validation protocols, including Installation Qualification (IQ) and Operational Qualification (OQ) for Purified Water Storage & Distribution System. (J.B. Chemicals & Pharmaceuticals Ltd, Panoli)
• Prepared and executed validation protocols for HMI, PLC, and SCADA for below systems (J.B. Chemicals & Pharmaceuticals Ltd, Panoli): Filling Machine, Auto Cartoning Machine, Capsule Filling Machine, Labelling Machine, Cage Blender, Blister Inspection System, Mixer Granulator System, Purified Water System, Fluid Bed Dryer, Dispensing Isolator, Coating System, Laser Drilling Machine etc.
• Engaged in Computer System Validation of laboratory instruments like High-Performance Liquid Chromatograph, LCMS, Atomic Absorption Spectrometer (AAS), Microscope, Gas Chromatograph, Auto Titrator, Temperature Monitoring System, UV Spectrophotometer, IR Spectrophotometer, Polarimeter, Viscometer for software like Clarity Software, LabSolutions, Empower, Perkin Elemer, LIMS Bridge, Tiamo, Caliber LIMS, Mettemp Log, Bridge Software for Temperature Monitoring etc. (J.B. Chemicals & Pharmaceuticals
• Prepared and Executed validation protocols for Server Qualification.
• Prepared and Executed validation protocols like IQ, OQ & PQ for Propix TrackNTrace System. (J.B. Chemicals & Pharmaceuticals Ltd., Panoli).

Bachelor of Engineering - Electrical Engineering - LC Institute of Technology (GTU) (2022)