Debajyoti Nayak

Over 11 years of experience in pharmaceutical industry with extensive experience in Pharmaceutical Qualification & Validation, Laboratory Software’s, ERP and Industrial Automation (SCADA, HMI and PLC Programming), Data Integrity and cGMP Compliance. Possess wide knowledge of US, EU and Indian Regulation. Proven record of accomplishment in handling large projects relating to Validation and Compliance. Carries out responsibilities in accordance with all GMP and safety requirements, SOPs and company policies and procedures. Effectively communicate with project teams and client stakeholders to meet project goals and objectives. Able to manage project outcomes by identifying, minimizing and mitigating risks. Strong leadership skills with the ability to motivate and inspire colleagues, with diplomacy.

• Broad experience on Pharmaceutical Process Equipment Commissioning & Qualification through development/review of validation plans.
• Tools worked on DocuSign, Veeva Vault, HP ALM, JIRA, Service Now, CRM applications, Microsoft tools.
• Software Qualified EQMS, LIMS, IDBS Polar, RPA (Automation Anywhere Bot), SAP S4/HANA and Historian System.
• Wide experience on Computer System Validation Projects through the development/review of validation plans.
• Project management / coordination activities through development/review of project plans/Gantt, status update reports/presentation, project issues tracker and technical problem solving, resources workload plans, meeting agenda/minutes, budget monitoring.
• As a Project Manager managed teams of various size, which includes Senior Consultant, Consultant and Junior Consultant as well.
• Led multiple projects from initiation to completion, ensuring timely delivery and adherence to budget constraints. “Managed cross-functional teams, fostering collaboration and effective communication to achieve project goals.
• CSV Qualification of Laboratory Systems - TIAMO, Chromeleon, Lab Solutions, ICDAS and Basis/V Comply.
• CSV Qualification - Environmental Monitoring System (EMS), Building Management System (BMS) and Building Automation System (BAS).
• PLC Validation for Roll Compactor, Rapid Mixer Granulator, Fluid Bed Processor, Fluid Bed Dryer, Octagonal Blender, Auto-coater, Blister Packing Machine, Inspection System, Bottle Packing Line, Serialization System, Secondary Packing (Cartooning Machine).
• Worked on VERISHIELD application for serialization and aggregation system with accordance to track and trace system (trace link).
• Working Knowledge on Siemens PCS system (signal exchange, handshaking I/O configuration and Siemens server database allocation)
• Worked with Grantek (Canada) for system Integration Project and Development facility for Building Automation System Project. (Allen Bradley, Delta and Siemens PLC)
• PLC/CSV Qualification for Manufacturing Vessel, Filtration Vessel, Mixing Vessel, Vial Washing Machine, Vial filling Machine, Ampule Filling and Sealing Machine, BFS Machine (Brevetti Angela) Depyrogenation Tunnel, CIP and SIP SKID, Cartooning Machine. Aseptic Filling Line, Lyophilize and Inspection Machine.
• Utility PLC/CSV Qualification – PW and WFI Generation and Distribution System, Pure Steam Generation System.

• May 2024 - Today, TEVA Pharmaceutical, Bangalore, COE (Data Integrity) for Global Projects, Managed the validation of SolidWorks software by developing detailed validation plans and protocols, including functional and performance testing. Collaborated with cross-functional teams to resolve issues and ensure the software met all regulatory and industry standards. Ensured seamless integration and compliance, supporting the software’s effective deployment in the engineering environment. Successfully led the validation of RPA Bots using Automation Anywhere, ensuring compliance with GxP and 21 CFR Part 11 regulations. Developed and executed comprehensive validation protocols, including IQ/OQ/PQ, and collaborated with cross-functional teams to address defects and ensure seamless deployment. Conducted risk assessments and managed change control processes to maintain continuous compliance and efficiency throughout the bot's lifecycle. Led the validation and implementation of the IDBS-Polar system for BioAnalysis and Bioprocess, ensuring adherence to regulatory requirements and industry best practices. Developed and executed comprehensive validation protocols, collaborated with cross-functional teams to resolve any system issues, and facilitated smooth integration into existing workflows. Used gALM (HPALM) software to manage end-to-end test planning, execution, and defect tracking, ensuring requirements traceability and generating actionable test reports. Utilized Jira for agile project management, issue and bug tracking, customized workflows, and integration with CI/CD pipelines to enhance team productivity. Leveraged ServiceNow for IT service management, CMDB maintenance, workflow automation, and service catalog management, providing detailed performance reports.
• Jan 2024 - Feb 2024, Square Pharma, Bangladesh, Senior Consultant, Worked as Senior Consultant for supporting CSV validation project: For Production equipment, Serialization, Aggregation system and EQMS.
• August 2023 - May 2024, Sudair Pharma, Riyadh, Saudi Arabia, Project Manager, Working as Project Manager for Validation Support for SAP S4/HANA, performing the following Modules: MM, Product Planning & Control, QM, PM, ATTP and SD Module. Full CSV activities support in Accordance with CFR 11/Annex 11, documentation creation/ review and execution URS BPM CSS Risk Assessment IQ OQ PQ Protocols/Reports Traceability Matrix Validation Report
• 24th July 2023 - 28nd July 2023, Mylan Sarigram Facility, Spain, Due Diligence Audit, Due Diligence Audit for MYLAN Sarigram Facility (women’s Health) on Behalf of Insud Pharma, Spain.
• 17th July 2023 - 22nd July 2023, Mylan Ahmedabad Facility, Spain, Due Diligence Audit, Due Diligence Audit for MYLAN Ahmedabad Facility (women’s Health) on Behalf of Insud Pharma, Spain.
• January 2023 - June 2023, Oncogenpharma, Malaysia, Consultant (PM), Worked as Consultant (PM) for CSV of Quality Systems, performing the following activities: Full CSV activities support in Accordance with CFR 11/Annex 11, documentation creation/ review and execution URS FRM Risk Assessment IQ OQ PQ Protocols/Reports Traceability Matrix Validation Report
• July 2022 - October 2022, NOVUGEN, Malaysia, Project Manager, Worked as Project Manager for Remediation Supporting Activities, performing the following activities: Full CSV activities support in Accordance with CFR 11/Annex 11, documentation creation/ review and execution URS FRM Risk Assessment IQ OQ PQ Protocols/Reports Traceability Matrix Validation Report Worked for Validation Support for SAP, performing the following activities: Retrospective Validation Material Management Quality Management Full CSV activities support in Accordance with CFR 11/Annex 11, documentation creation/ review and execution URS FRM Risk Assessment IQ OQ PQ Protocols/Reports Traceability Matrix Validation Report
• January 2022 - June 2022, Sandoz Pvt Ltd, India, Senior Consultant, Worked as Senior Consultant for Qualification Support for Manufacturing Facility, performing the following activities: Qualification of manufacturing facility equipment (Laboratory & Production) Qualification Plan Functional Risk Assessment IQ OQ PQ Sensor Risk Assessment

• Certified PLC Programmer, 2014
• Certification on Hardware and Networking from Central Tool Room & Training Centre (MSME), 2008
• PQE- Cybersecurity Awareness, E-learning Platform, 2021
• Computer system Life cycle, E-learning Platform, 2021
• Computerized Systems Data Integrity Assessment, E-learning Platform, 2021
• CSV Data Collection, E-learning Platform, 2021
• Data Integrity principles in PQE Service Delivery, E-learning Platform, 2021
• Data integrity Regulatory trends, E-learning Platform, 2021
• Excel Validation, E-learning Platform, 2021
• GMP Basics, E-learning Platform, 2021
• Processes & Systems in a MFG Plant, E-learning Platform, 2021
• Regulated ER & ES, E-learning Platform, 2021
• Regulated Processes to Maintain the Validated Status, E-learning Platform, 2021
• Regulatory Background, E-learning Platform, 2021
• Specifications, E-learning Platform, 2021
• Testing, E-learning Platform, 2021
• SOP QM 001, E-learning Platform, 2021
• Good Documentation Practices, E-learning Platform, 2021
• Commissioning and Qualification, E-learning Platform, 2021
• Equipment Qualification & Calibration, E-learning Platform, 2021
• Tutorial HVAC Design-Reg. Expectations-Qualification, E-learning Platform, 2021
• Visual Inspection, E-learning Platform, 2021
• Computer System validation basics, E-learning Platform, 2021
• CSV Planning, E-learning Platform, 2021

CSV CSA & Data Integrity Expert (Senior Consultant at PQE)

• Eu Annex 11
• 21 CFR Part 210-211
• ASTM E2500
• GMP Auditing
• ISA-95
• CAPA Management
• ANVISA
• USFDA
• SCADA/HMI/PLC
• DMS
• ERP
• LIMS
• JIRA

Nationality: Indian

• Odia
• Hindi
• English