Naga Rama Krishna Raju Kattamuri

Project 1

CSV (Computer System Validation)- SAP V

Client -Vasudha Pharma Ltd.

Role: Project Manager.

Responsibilities

• Guiding team in creation of documents for Computer system Validation for SAP R/3 like Validation Plan, GXP documentation, IRA, (Initial Risk Assessment) Functional Specification, Design Specification, FRA,(Functional Risk Assessment) Installation Qualification Protocol, Operation Protocol, Performance Protocol , Validation Summary report.
• Established Agile methodologies for validation
• Supported client in creation of Functional SOP for SAP modules
• Ensured Project Deliverables as per Agile methodologies
• Recommendation of SAP practice as per GAMP and GMP guidelines to client.
• Helped client to establish Proper SOP for SAP and CSV life Cycle for all GMP and GXP systems

Project 2

CSV - Lab Equipment

Client -SMS Pharma

Role: Project Manger

Responsibilities

• Collaborated with vendor to negotiate contracts that resulted in cost savings without compromising quality or performance requirements.
• Development of content related to Computer system validation for Lab Equipment
• Guide CSV tam in preparing of validation plan, risk management plan and perform functional risk assessment per applicable compliance with GAMP 5 quality risk management and other predicate rules pertaining to concerned regulatory agency (FDA, EMEA, PMDA).
• Monitoring and review of documents prepared by t team
• Coordinating with QA, QC and IT stakeholders on project progress, Identifying risks and work on mitigating risks with proper project plan
• Study and Analysis of business requirements. Make sure GxP guidelines are followed stringently.
• Guide and mentor validation engineers in drafting qualification protocols (Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Data Migration Qualification (DMQ) and Disaster Recovery Qualification (DRQ)) for validating computer system software configuration, business functionalities, disaster recovery and data migration scenarios.
• Review and approve all system-related validation deliverables for end-to-end lifecycle including user requirement specification, functional requirement specification, risk assessment, design specification, IQ/OQ/PQ/DMQ/DRQ Protocols and test results/summaries, operations manuals and training manuals.
• Qualify disaster recovery of GxP systems.
• Accelerated project timelines by contributing to efficient sprint planning and agile methodologies implementation.

• Negotiated contracts with vendors for cost-effective procurement of services essential for successful project completion.
• Championed continuous improvement initiatives that resulted in process enhancements leading to greater client satisfaction.
• Fostered strong relationships with clients, leading to increased contract renewals and referrals.
• Demonstrated expertise in change management processes, facilitating smooth transitions and minimizing disruptions to ongoing operations.

Project-1

SAP Support & Implementation of Modules necessary

Client -Sanzyme Pharma Ltd

Role: Project Manager SAP & CSV execution

Responsibilities:

• Ensuring SAP functionality in accordance with GXP process and monitoring day-to-day operations of SAP modules such as MM, P.S SD, PP, ABAP, and Basis, allocating day-to-day issues to teams, and monitoring deliverables on time for both support and implementation of new modules.
• Handling daily scrum calls
• Developing and correction of SOP's in GXP process
• Coordinating with Quality Assurance team in CAPA for incident or deviation management
• Establishment of SOP for new developments in GXP process

Project-2

CSV GXP Process review and recommendation and QMS development

Client - Granules Omnichem (AJi Bio)

Role : Project Manager

Responsibilities

• Monitoring CSV team and reviewing CSV deliverables
• Validation of GXP process in IT and identifying GAPS
• Interacting with GXP process owners, understanding their procedures, and identifying gaps in GXP practice.
• Providing recommendations and revising or developing new SOPs as necessary.
• Defined SDLC guidelines and support Reviewed requirements and functional solutions
• Established team to develop QMS in SharePoint (on premise)
• Coordinated with team for development of process in QMS like Change request, Incident Management, Deviation Management, CAPA forms, OOS.

Project -3

Client -Plum Soft

Role: GXP SME for Plum ERP

Responsibilities

• Validate Plum ERP, find gaps, and recommend application GXP requirements.
• Establishing documentation process for GXP process
• Entered into contract of validation of Plum ERP in pharma companies with Plum soft .
• Guided in development of Document Management system and Quality Management system for Pharma

Project -3

GAP Assessment

Client : Daicel

Role: GXP IT Auditor

Responsibilities

• Auditing documentation in GXP area and identifying gaps
• Recommendation of mitigation for gaps Identified
• Creation of Network Diagrams for GMP areas.
• Established SOP for all GXP process.
• Performing Audits yearly twice on IT process

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• Analyzed architecture design, scoping, implementation, testing and deployment needs to define project requirements.
• Coordinated with management teams to plan, develop, align and execute strategies that would meet client's vision, mission and purpose.
• Delivered effective integrations of warehouse management system software applications to centrally manage tasks.
• Analyzed network security and current infrastructure to assess areas in need of improvement and develop solutions in GXP environment.
• Reviewed and assessed architecture design, implementation, testing and deployment needs to identify project requirements and costs.
• Coordinated SAP, WMPS, Vendor Management portal, SAP MRP projects, including defining scope, managing milestones and maintaining strong relationships with all stakeholders for Hetero group
• Provided expert technical support, resolving complex issues promptly while maintaining high levels of customer satisfaction.
• Optimized IT infrastructure by upgrading hardware, software, and network components for improved performance.
• Established business continuity plans to minimize downtime during unexpected events or system failures.

• Identified and solved technical Functional issues in Inventory Management.
• Implemented SAP-PS (Project System) W.M (Ware House Management) Vendor evaluation, Subcontracting process Stock transfers.
• Trained end-users of SAP PS and WM and MM on use, functionality and application to business problems.
• Created support documentation that empowered and enabled user community to extend skills, leverage system features and find resolutions to questions without intervention from support team.
• SME for the Warehouse management Portal
• Preparation of GMP and GAMP documentation for the GXP applications
• Validating al Applications used in GXP area of Hetero Group.
• Writing CAPA for incidents and deviations for SAP and other Customized applications in GXP area.
• Coordinating with the Corporate Quality Assurance team and the Plant Quality Assurance team to raise and close change requests for development or changes to existing applications for entire Hetero Group.
• Appearing Audits like FDA, WHO and customer Audits from Corporate IT at plants for GXP applications developed and implemented in Hetero group.
• Developing IT assessment categorization of software based on GAMP -5 and establishing documentation based on the category
• Monitoring of CSV for all the IT applications and Lab equipment.
• Making sure the application meeting all the GXP (GMP &CGMP) during designing and development phase.

• Traveled to client locations to implement SAP solutions, and offered post-installation support services.
• Consulted with network engineering staff to evaluate hardware and software requirements for new system development.
• Researched, designed and implemented scalable applications for data extraction, analysis, retrieval and indexing.
• Worked closely with software development and testing team members to design and develop robust solutions to meet client requirements for functionality, scalability and performance.
• Consulted regularly with internal customers on application development project status, new project proposals and software-related technical issues.