Manohar Kumar Email & Phone Number

Bengaluru, Ka, In

Bengaluru, Karnataka, India

Job Description:1. Responsible for ensuring the compliance of all enterprise GxP computerized systems.2. Accountable for timely deliverable of validation activities for enterprise GxP computerized systems as a QA approver.3. Accountable for instrument life cycle of enterprise GxP computerized systems as a QA approver (periodic reviews, data migration, system retiral/disposal.)4. To ensure Zero critical points in any of the audits with respect to processes in enterprise GxP computerized systems.5. To coordinate with the Information Technology department and other stakeholders related to existing data governance program for its timely completion. 6. To perform any other task assigned from time to time.

Bengaluru, Karnataka, India

Job Description:• Lead Validation project activities ensuring compliance and expectations are met.• Guide project managers for validation activities complying to various guidelines, 21 CFR Part 11, Applications & Infrastructure validations including IQ, OQ, PQ.• Reviewing and approving digital and IT system validation lifecycle deliverables including Validation Plans, specification documentation, system configuration, Traceability Matrix (RTM) in compliance with CGMP and GDP requirements.• Establish and maintain end-to-end Validation guidance document and framework for managing all validations needs.• Clearly communicate validation strategies and facilitate all aspects of a risk-based life cycle approach for Computer System Validation on all Digital projects• Participate in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix.• Review of executed Test Scripts/Protocols and Test Results.• Responsible for creating procedural framework covering GAMP, QMS (Quality Management Systems)21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments and other regulatory requirements needs based on the systems need/scope internal/external use in GMP area. • Ensure compliance to applicable development life cycle / models (Waterfall, Agile methodologies, product development, rapid application development, iterative development etc.).• Perform additional tasks as assigned by Reporting Manager / HOD

Shamirpet, Telangana, India

Job Description:• Conducted audits and inspections for GxP compliance.• Implemented disaster recovery and backup protocols for GxP systems.• Oversaw timely compliance of Audit Trail review, Periodic evaluation, Data backup/restoration/archival, and Time synchronization of Computerized systems.• Ensured full GxP system compliance with regulatory standards.• Provided daily training on compliant computerized system usage and recommended system upgrades.• Contributed to validation of various systems, software, and equipment in the GMP environment.• Documented URS, IQ, OQ, and PQ for Version Control and Data Solutions systems, and created Validation and Test plans.• Ensured regular functional backup and restoration for GxP systems.• Developed SOPs for daily CSV system administration tasks.• Oversaw user requirement fulfillment via Biological E. Ticketing Application (BETA).• Proficient in Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and GAMP 5 guidelines.• Monitored CSV deliverables against schedules, ensuring compliance with stakeholders. Proficient in SDLC and experienced with TrackWise, DMS, and LMS.

Wanaparthy, Telangana, India

Job Description:• Executed Commissioning, Operation, and Maintenance (O&M) of a 6.0MW Captive Power Plant (CPP) with a 50 TPH AFBC Thermodyne Boiler, ensuring adherence to industry standards.• Conducted Preventive Maintenance for the entire plant's Electrical & Instrumentation System, supported by monthly MIS Reporting, aligning with industry requirements.• Managed Electrical and Instrumentation Departments, ensuring adherence to Standard Maintenance and Operation Procedures.• Implemented safety Hardware interlocking measures for plant enhancement, in line with industry standards and regulations.• Demonstrated expertise in DCS logic, troubleshooting, and implementation of systems from ABB, Forbes Marshall, Siemens & YOKOGAWA, complying with industry protocols.• Maintained equipment History Cards, assessing conditions and Operation and Maintenance costs, meeting industry requirements.• Executed Preventive, Predictive, and Corrective maintenance strategies to minimize downtime and enhance plant availability, aligned with industry protocols.• Managed all plant areas (AHP, CHP, BOILER, TURBINE, WTP & BOP) adhering to International Safety standards, incorporating industry-specific standards for compliance.• Commissioned 6MW Turbine (Make: Triveni – 6MW) and related Instrumentation Systems and Panels (TSP, TGP) adhering to industry standards.• Commissioned Electrical Panels (MSCP, AVR, MCC Cum ACDB, RMP, RTCC, and Battery Charger Panels) in accordance with industry protocols.• Performed overhauling maintenance of Alternator (Make: TDPS – 8125KVA) and supervised Commissioning of VCB Panels (11KV – 1250KVA) meeting industry criteria.• Conducted overhauling maintenance of Compressors (Rotary – Screw Type) adhering to industry standards.

Dachepalle, Andhra Pradesh, India

Job Description:• Managed Electrical & Instrumentation O&M for Cement plant (Kiln - 5000 TPD & Packers - 16+8+8) & 30MW Captive Power Plant (CPP) with 110 TPH AFBC IJT Boiler.• Oversaw maintenance & troubleshooting of Electrical & Instrumentation across all plant sections, including Coal Plant, Coal Mill, Cement Mill, Packing Plant, DM plant, ASH Handling, Coal handling, Boiler, and Turbine section.• Conducted Installation, Configuration & Calibration of Actuators, Control Valves, and other Field Instruments (Pressure, Level, Temperature & Flow).• Generated reports on daily plant activities to track overall progress during operations and shutdown.• Demonstrated hands-on experience with Detailed Instrumentation of Cement Plant’s Grinding & Packing Unit.• Ensured timely commissioning, inspection and handover of the manufacturing facility in line with the standard governing mechanism.

Bachelor Of Technology - Btech, Electronics And Communication Engineering, B(77.81%)

Diploma, Electronics & Communication Engineering, A(93.25%)

Ssc, High School/Secondary Diplomas And Certificates, 80%