Jaikishan Patel Email & Phone Number

Brantford, Ontario, Canada

• Author the full suite or computer system validation documents (e.g. VP, URS, DS/CS, IQ/OQ/PQprotocols and reports, VSR, etc.) as per defined validation approach.• Coordinate and manage test case authoring, execution, review and approval process.• Execution of protocols/test procedures and verify results as necessary.• Perform periodic reviews of systems.• Develop and execute remediation plans for existing systems to ensure compliance withapplicable regulations.•… Show more • Author the full suite or computer system validation documents (e.g. VP, URS, DS/CS, IQ/OQ/PQprotocols and reports, VSR, etc.) as per defined validation approach.• Coordinate and manage test case authoring, execution, review and approval process.• Execution of protocols/test procedures and verify results as necessary.• Perform periodic reviews of systems.• Develop and execute remediation plans for existing systems to ensure compliance withapplicable regulations.• Implement validation programs as per the Global Computer System Validation Master Plan/GISTesting Methodology.• Support audit defense during internal or external audits.• Coordinate with the project leaders/managers and other team members to ensure timelycompletion of related tasks.• Work with GIS or other support groups to outline the impact of changes based on whichvalidation testing is performed.• Effectively communicate the validation activities and deliverables to the project team.• Provide support to implement and maintain the Computer System Inventory.• Resolve issues with internal customers, contractors and other internal stakeholders. Show less

Mississauga, On, Canada

• Setting up the Tablet Compression system to produce Tablets of required Thickness, Weight and Hardness according to SOPs• Picked, prepared and verified the Batch components and Quantity against the Work Order and Material Requirement List (MRL) and prepare for Batch Processing Readiness (Greenline)• Performing Compounding activities wearing PAPR, Half mask and Tyvek Suits • Finalizing the batch campaigns by completing the Batch Work Order Documentation with high accuracy and… Show more • Setting up the Tablet Compression system to produce Tablets of required Thickness, Weight and Hardness according to SOPs• Picked, prepared and verified the Batch components and Quantity against the Work Order and Material Requirement List (MRL) and prepare for Batch Processing Readiness (Greenline)• Performing Compounding activities wearing PAPR, Half mask and Tyvek Suits • Finalizing the batch campaigns by completing the Batch Work Order Documentation with high accuracy and integrity• Carried out Acceptable Quality Limit (AQL) inspection and performed In Process tests like Disintegration, Friability and Hardness Test• Cleaned the Critical Product contact Equipment parts in accordance with Cleaning SOP to remove Microbial, API and Detergent residues• Completed In Process and Final product quality inspection of tablets and capsules for any defects such as chipping, foreign material, mottling and capping using Kalish Roller Spector Machine Show less

Mississauga, Ontario, Canada

• Preparation of Installation Qualification, Operational Qualification protocols for Laboratory Information Management System.• Preparation of GAP Analysis for Standalone Laboratory instruments like HPLC, GPC, LCMS, FTIR, UV Polarometer.• Assist in IT policy implementation in Computer Systems used in Laboratory.

Vadodara, India

• Performed Validation of PLC/ SCADA based Computerised systems at US FDA approved Sun Pharmaceuticals Industries Limited, Emcure Pharmaceuticals, etc• Prepared, reviewed and executed Validation documents like User Requirements Specification, Project Validation Plan, Functional Specification & Design Specification, FRS, High Level Risk Assessments, Installation, Operational & Performance Qualification and Validation Summary reports according to Master Validation Plan (MVP)• Identified… Show more • Performed Validation of PLC/ SCADA based Computerised systems at US FDA approved Sun Pharmaceuticals Industries Limited, Emcure Pharmaceuticals, etc• Prepared, reviewed and executed Validation documents like User Requirements Specification, Project Validation Plan, Functional Specification & Design Specification, FRS, High Level Risk Assessments, Installation, Operational & Performance Qualification and Validation Summary reports according to Master Validation Plan (MVP)• Identified and developed Test strategy and test plans based on User requirements, Acceptance criteria and System specifications• Solved constraints during validation process and advised on Corrective actions like Deviations (DRs), Change control, Addendum, etc. according to Regulation Compliance & Regulatory requirements• Reported test related activities, findings and analysis of test data in oral and written communication to clients• Communicated with System/ Software Vendor on behalf of Project team to get the GxP system implemented in compliance with GAMP guidelines• Coordinated validation activities with Information Technology (IT) department and concerned user department. • Verifying PLC Inputs & Outputs, Communication between PLC and SCADA, Access Levels and Access Rights, SOPS, User Manual of GxP system• Familiar with Fedegari Autoclave, Vial Washing, Tunnel & Filling System, Labelling and Pouch Wrapping, Checkweigher system, Building Automation System (BAS/BMS), Environment Monitoring System (EMS), WFI, RO & Purified Water systems, HPLC, GPC and GC (Chromatography), Iron Sucrose Skid, SIP & CIP Mobile Vessels, etc Show less

Mumbai, India

• Sent to Costa Rica, Central America on Deputation for 13 months.• Installation of devices, Instruments and systems required for Automated Manufacturing Facility. • Periodically schedule Preventive Maintenance and get it performed by Technicians. • Supervising Calibration and Validation activities of Measuring Instruments and Process Automation systems.• Troubleshooting and problem solving of Automated Machineries in case of breakdown.• Evaluation of systems and… Show more • Sent to Costa Rica, Central America on Deputation for 13 months.• Installation of devices, Instruments and systems required for Automated Manufacturing Facility. • Periodically schedule Preventive Maintenance and get it performed by Technicians. • Supervising Calibration and Validation activities of Measuring Instruments and Process Automation systems.• Troubleshooting and problem solving of Automated Machineries in case of breakdown.• Evaluation of systems and recommending design modifications / equipment repair.• Procuring and maintaining stock of frequently required spare parts and wear and tear items. Show less

Bachelor'S Degree, Electronics And Telecommunication

Activities and Societies: Sports Activities like Cricket, Badminton, Football and Volleyball. Also volunteered Blood Donation Camps.

Diploma, Industrial Electronics

Activities and Societies: Activities included Industrial Visits to Coca Cola (Wada Plant), Parle Products (Vile Parle), Bhakra Nangal Dam.