Nirav Patel
Etobicoke
Summary
An enthusiastic, flexible, innovative, and self-disciplined individual seeking an opportunity to play a challenging and creative role in the sparkling environment of any Computer System Validation and Instrumentation Activities with total commitment for excellence and highest degree of professionalism. Having 7 years of professional experience in Validation Practices with a good understanding of GxP standards, Risk Assessment, Validation Protocol, FMEA, 21 CFR Part 11, EU Annex 11 Guideline, GAMP guide and maintenance of plant machines to maintain quality production of pharmaceutical industry.
Overview
10
10
years of professional experience
Work History
Metrology & Computer System Validation Consultant
Trident Engineering Inc.
03.2022 - Current
- Authored, reviewed, and approved validation plans, business requirements, computer validation test scripts and validation summary report.
- Lead and manage Computer System Validation projects of GxP application as per FDA, 21 CFR Part 11, ISPE GAMP5, Health Canada and ICH E6 guidance.
- Study, analyze and prepare business requirements for in-house and third party provided systems.
- Perform risk assessment for new and existing validated systems.
- Guide and provide support in drafting Installation Qualification (IQ), Operation Qualification(OQ), Performance Qualification (PQ), Validation Plan (VP), Traceability Matrix (TM), Existing Test Case review.
- Developed CSV content for specific systems, quality documents to support validation process and execute periodic review of business critical, business required and business tools systems.
- Participate in regulatory and customer audits as CSV representative to provide support for any observations and corrective actions implementation by GAP analysis and CAPA procedure.
- Support development team for architecture and functional design documentation.
- Provide On filed Extensive support to Calibrates and repairs analytical instrumentation that monitors or controls flow, level, temperature, pressure, acidity, conductivity, and humidity. Provide on field support to Calibrates, commissions, configures, installs, and troubleshoots all pneumatic, electronic, electrical, mechanical, and analytical instrumentation devices.
- On had experience of advanced calibration equipment such as Hart Communicators, and programs.
- Help Journeyman and other apprentices with the maintenance, replacement, and installation of equipment.
- Capable of setting set points on safety shutdown device(s) & should be able to complete calibrations unattended in most situations.
- Working on or around any ‘live' process or equipment including isolation and de-pressuring of any system following SOPs and safety procedures.
Metrology Technician
Septodont (Novocol Pharma)
05.2021 - 03.2022
- Maintains the Master and Working Calibration Specifications for all existing and new equipment as required.
- Schedules and coordinates the completion of calibration activities with other departments.
- Recognizes and/or anticipates problems, and takes necessary actions and/or notifies responsible individuals so as not to significantly affect schedules.
- Performs timely calibrations on facilities, warehouse and laboratory equipment as specified in various calibration Standard Operating Procedures. Calibration of measuring and test equipment includes electronics, time and frequency, temperature, pressure, mass, force, sound, light and flow disciplines.
- Completes/reviews and files all calibration documentation. Ensures all associated documents, tags and incident reports are completed, filed or placed appropriately.
- Initiates Change Control Request forms to make necessary changes to calibration Standard Operating Procedures, master calibration files and/or the computerized calibration program.
- Writes, evaluates and maintains calibration Standard Operating Procedures as required to ensure compliance with GMP guidelines and company goals.
- Initiates Deviation Incident Report forms to notify of any instruments that are out of tolerance or that have not been calibrated on time.
- Supports the validation department in validation projects.
Equipment Calibration and Maintenance Specialist
Cliantha Research
10.2020 - 05.2021
- Responsible for Thermal Validation, Maintenance and Calibration of the equipment used in the clinical operations.
- Performs analysis of calibration results and maintains calibration history files and documentation.
- Troubleshoot general equipment issues and maintain all logs and required documentation.
- To complete day to day maintenance tasks and play a vital role in the upkeep of the equipment.
- Ensures that Equipment is calibrated and maintained as per the SOPs and relevant GxP regulations.
- To maintain a record of issues that occurs during the course of the day. This includes completed testing and any problems encountered.
- Maintains calibration records, instrument tagging, change control documentation and deviation notifications.
- Ability to determine priority for the replacement, repairs, and upgrades based on system conditions and functional needs in consultation with the manager.
- Assist in writing SOP's / Work Instructions relating to the calibration and maintenance of all equipment.
- Ensure compliance with appropriate Cliantha Research SOPs, GLP, GDP and ICH guidelines.
Instrumentation Engineer
Intas Pharmaceuticals Limited
08.2015 - 08.2018
- Maintains procedures pertaining to the validation of equipment, facilities, utilities and computerized systems according to regulatory requirements (EU, FDA) and industry standards/guidance documents.
- Works with internal departments (Operations, Maintenance, Quality, and R&D) to establish specifications.
- Drafts and executes qualification protocols (IQ, OQ, PQ) for equipment, facilities, utilities, and computerized systems. Where required, trains equipment operators or other staff on validation and qualification protocols. Prepare qualification summary reports based on findings.
- Supports other departments with process and equipment Risk Assessments.
- Produces and / or executes CSV deliverables in accordance to the company's global CSV process.
- Conducts assessments of computerized systems to determine overall system risk and Electronic Records / Electronic Signatures (ERES) / 21 CFR Part 11 capability and functionalities.
- Work with QC, R&D, Engineering and Operations to enforce CSV guidelines, policies and procedures for control systems, automation, analytical equipment, and IT applications.
- Performs periodic assessments for GMP qualified/validated equipment and determines if the equipment has maintained its qualified/validated state or requires re-qualification.
- Performs retrospective equipment validations on legacy equipment.
- Participates in the generation of annual product reviews to assess if re-validation of GMP processes is required.
- Prepares, reviews, and approves quality documents, such as SOPs, deviations, investigations, corrective/preventive actions, and change controls.
- Participate in the formal process of continuous improvement of the Quality Management System (QMS) and procedures to maximize efficiencies and safety.
- Developing and executing validation protocols, specifically Thermal validation, and Kaye Validator experience.
- Having operational and maintenance knowledge of Rapid Mixture Granulator, Fluid Bed Dryer, Blender, Automatic coating machine (Sejong/Cadmach/Dr. Pharma), Tablet Compression machine (Sejong/ Fette), Tablet Inspection machine and packing line including Blister packing machine, Carton packing machine, Vision systems and Oncology Parenteral equipment like Vial washing machine, Depyrogenation Tunnel, Vial filling, stoppering machine, Lyophilizer (GEA/Tofflon) and packing line of vial.
- Hand on experience of PLC /HMI programming with Allen Bradley, Siemens, and Omron.
- Handle/manage the calibration activity i.e. annual scheduling and execution of same within defined frequency with proper documentation.
Senior Computer System Validation Engineer
Kevin Technologies Private Limited
07.2014 - 08.2015
- Responsible for computer system validation (PLC, SCADA, Software, BMS, Camera system, water system, TMS, etc.) Activity at various projects sites.
- Manage & maintain compliance of SAP system in highly regulated environment.
- Implementation support & compliance of Track Wise Quality Management System, LIMS in highly regulated environment.
- Performs GxP, 21 CFR part 11(ER/ES) Applicability, Risk assessment and CCR Assessment for Computerized Systems.
- Review of All CSV documents which is performed by other Team members.
- Categories the equipment and preparation & execution of documents regarding to Computer system validation like Validation Master plan, GxP, URS, SRS, PVP, IRA, FMEA, FDS, FRA, IQ test scripts, OQ Test scripts, Traceability matrix & Summary report.
- SOP Preparation regarding CSV.
- Presentation preparation and provide training regarding CSV to project clients.
- Performed PLC, HMI, SCADA and control system validation of various plants, formulation, parenteral & Utilities in various pharmaceutical companies.
- Having experience of designing validation protocol for SUN pharmaceuticals Limited with Lachman Consultants (USA).
Education
Diploma - Industrial Instrumentation And Process Control Technician
Confederation College of Applied Arts And Technology
Thunder Bay, ON06.2020
Bachelor of Engineering - Instrumentation And Control Engineering
Gujarat Technological University
Gujarat, India05.2014
Skills
- Instrument Calibration
- Standard Operating Procedure (SOP)
- Change Control
- Regulatory Affairs
- Qualification
- FAT/SAT
- Computer system Validation (PLC/SCADA/DCS)
- Risk Assessment
- Green and Brown Field Project
- Commissioning
- Machine Installations
- Maintain Critical spares
- Data Integrity & CQV
- IQ/OQ/PQ
Accomplishments
- Computer/Control System Validation projects completed for pFizer, Cadila Pharmaceuticals, RPG Life science, Amneal, Lupin, Mylan Laboratories, Gufic Life science, SUN Pharmaceuticals, Intas, Fresenius kabi, Torrent Pharmaceuticals and Sanofi.
- Designing CSV protocol for SUN pharmaceuticals Limited with Lachman Consultants (USA).
Timeline
Metrology & Computer System Validation Consultant
Trident Engineering Inc.
03.2022 - Current
Metrology Technician
Septodont (Novocol Pharma)
05.2021 - 03.2022
Equipment Calibration and Maintenance Specialist
Cliantha Research
10.2020 - 05.2021
Instrumentation Engineer
Intas Pharmaceuticals Limited
08.2015 - 08.2018
Senior Computer System Validation Engineer
Kevin Technologies Private Limited
07.2014 - 08.2015
Diploma - Industrial Instrumentation And Process Control Technician
Confederation College of Applied Arts And Technology
Bachelor of Engineering - Instrumentation And Control Engineering
Gujarat Technological University
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