Ramanujam Narayanan

• CSV Compliance Assessments and determining the risk level
  
• As applicable, prepare a milestones of Val deliverables for a Project ·
  
• During CSV Concept and Planning Phase, as applicable, draft/review and approve various plans as CSV Lead - → Validation Plan → Data Integrity/Migration → Security Plan → Business Continuity Plan and Disaster Recovery Plans → Training Plan.
  
• During Requirements, Design and Build Phase - Coordinate, Review and approve → User/Functional/System/Data Migration Requirements → Functional Risk Assessment at Requirement Level → Protocols (pre and post review and approvals) - For Installation/Operation/Performance/Data Migration Qualification → Con fig/Design specification documents → Requirement Traceability Matrix → Standard Operating Procedures on system intended use and system administration including Data Migration
  
• During Validation Phase - draft, collaborate, review and approve → Qualification protocol execution and reporting - IQ, OQ, PQ, DMQ in GxP sensitive environments (as applicable) → Review objective evidence at protocol level and sign-off → Testing Summary Reports for
  
• During CSV Release and Maintenance Phase - draft, collaborate, review and approve → Qualification protocols execution in Prod - IQ, PQ, DMQ → Review objective evidence at protocol level and sign-off → Validation Summary Report
• Experienced and Validated Veeva Vault products such as Qualitydoc Content Management , Validation Management software while implementing to major pharma in world.
  

Qualification/Validation of tools/utilities interacting with GxP sensitive environments

• Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and ServiceNow tools
  
• Review and draft standard operating procedures the system and integrated tools refresh, upgrades, patching etc. Project CHG management - CSV support to maintain the validated state.

• Assist with the development of SAP Modules system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
• Analyse the GxP Sensitive requirements, IT SoX implementation, Functional and Non functional requirements in SAP modules
• Facilitate the implementation teams in the proper execution of validation documents
• Data Migration process from SAP EPH7 to SAP S4 HANA
• Created Master Validation Plan across 7 landscapes, individual Validation plans for each region
• Evaluated proposed changes to validated computer systems and recommend level of validation activities required
• Coordinated audits of internal computer systems validation activities, protocol and procedures, and prepare responses
• Identify and qualify all computer systems which impact cGMP operations using a risk based methodology
• Developed CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Participated in all standup meetings, Sprint handling, product owners, update Jira on regular basis from validation perspective
• Developed, Trained and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
• Act as a CSV Lead for SAP Modules - MM, PM, finance, Master data governance etc. validation projects
• Performed project management activities for CSV process within the scope of an overall system project
• Work with overall project manager to include validation activities in implementation timelines
• Managed internal CSV resources to facilitate completion of qualification activities
• Ensured initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents.
• Work closely with Validation QA Compliance to ensure appropriate validation of cGMP SAP validation
• Conduct or facilitate validation and 21 CFR Part 11 training

• Collaborate cross-functionally with design, engineering, marketing, and sales teams to identify and deliver new product solutions and enhance existing portfolio
• Develop and execute detailed product roadmaps using Agile methodology
• Partner with design and engineering teams on design concepts and product iterations
• Leverage beta testing, data analytics, and user research to identify and experiment with new formats and measurement methods to improve performance
• Own product strategy, including go-to-market plans, positioning, and messaging
• Evangelize product vision to key stakeholders using customer research, data analysis, performance metrics, and use cases to build consensus
• Produced Team availability, Status, Project health, Risk Assessment, Time tracking and baseline reports each weekly, updating customers and senior leaders on progress and roadblocks
• Gathered requirements, defined scopes, allocated resources and established schedules meeting or exceeding project demands
• Managed and motivated project teams to promote collaboration and keep members on-task and productive
• Maintained excellent attendance record, consistently arriving to work on time
• Monitored social media and online sources for industry trends
• Managed quality assurance program, including on-site evaluations, internal audits and customer surveys
• Global QMS tool implementation for the well know Pharma player in the world

Infrastructure Validation Manager:

• a documented and approved risk-assessment report detailing what risks the infrastructure (e.g., a server) poses to systems and applications that can directly impact drug product quality and safety and data integrity;
• a qualification and validation plan or protocol that contains the purpose and scope, roles and responsibilities, coverage, periodic review procedures, maintenance procedures, administration procedures, documentation, and so forth;
• network requirements, design, and testing documentation;
• mandatory documentation, including installation SOP, physical and logical security SOP, backup and restoration SOP, disaster recovery SOP, business continuity SOP, change control SOP, and document management SOP;
• installation qualification and operational qualification documents;
• installation verification records that prove that components of the IT infrastructure were installed and configured properly and in accordance with specifications and procedures and that there were no deviations from standard installation;
• operating procedures and instructions for those who run the infrastructure;
• administration procedures;
• training SOP or manuals;
• qualification reports;
• infrastructure retirement and revalidation procedures;
• data management, record retention, and archiving procedures;
• audit trail procedures.

LIMS project Implementation -

• Managed and maintained document control systems
• Formulated and executed quality system procedures and standards. Developed certificates of analysis and supported quality systems
• Designed and implemented LIMS Master data
• Administered internal laboratory and related troubleshooting apps. Suggested and executed enhancements for lab systems to achieve laboratory objectives
• Conducted training sessions relating to quality systems. Prepared and documented product specifications for all products
• Formulated and executed requirements for software programs
• Developed and implemented automated systems to record workflows. Maintained and updated lab properties as per LIMS dictionary updates. Participated in initial unit testing and lab functionality
• Assisted in understanding of LIMS technical aspects and relational databases
• Designed and executed user interfaces for new modifications
• Conducted system requirement analysis and documented laboratory implementations
• Provided assistance in identification of technical enhancements and change requests
• Managed opening and closing procedures and recommended changes to enhance efficiency of daily activities

Statistical Tool Validation: MInitab and JMP

• Developed validation plans along with designing, maintaining, and executing validation tests for Minitab and JMP
• Collaborated with Product teams to validate and maintain validation packages for all Statistical tools like MInitab and internal tool
• Generate and execute verification and validation (System Testing, IQ, OQ, PQ, UAT) documentation for Minitab and JMP
• Performed gap analysis on Business requirements VS Minitab requirements and JMP
• Implement and apply risk-based system characterization, verification and validation, and change management approach throughout the SDLC
• Facilitate the computer system risk assessment to identify governing regulations and Deliverbales of Minitab.
• Implemented and apply validation methodology for GXP systems developed using Waterfall and Agile methodologies.
• Worked with system vendors and development teams to develop, harmonize, leverage and documentation (eg. Specifications, Vendor/development testing, Reports, etc.) for Minitab and JMP
• Supported computerized systems change management and periodic review processes.
• Supported regulatory inspections and internal and partner audits, and implements corrective actions as needed in
• Prepared life cycle, validation and project summary reports.
  
• Maintain validation schedule and prepare status reports.
  
• Ensure all project and life cycle documents achieve the goal of traceability, and these are all retained in the designated document repository (paper or electronic) and approved in accordance to the prescribed SOPs.

Confidential

Applications: LIMS and Trackwise, SAP and Argus.

• Responsible for computer systems (full range of scientific applications) validations and their compliance with respect to various guidelines like 21 CFR Part 11, PIC/S, GAMP. Additional responsibilities like critical technical support to Scientific Applications & IT/IS Services.
• Managed large-scale projects per PMO and SDLC Agile and Waterfall methodologies and procedures.
• Managed the implementation, qualification/testing, and release of the infrastructure environments/components and ERP Applications
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards.
• Prioritized, monitored, and reported project progress against planned objectives and success criteria.
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders.
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance.
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team.
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs.

SAP QCS Consultant

• Experienced in Quality approver role as part of change advisory board
• Experienced in performing quality reviews for design documents
• Experienced in reviewing the testing document from a quality assurance perspective
• Experienced in maintaining staff database as well as training compliance management
• Experienced in defining and maintaining SOPs and quality standards
• Experienced in compliance issue management and root cause analysis
• Knowledge of documentation standards and methodology
• Performed in Computer Validation activities
• Compliance lead for North America Region for SAP
• Able to lead, influence and coach complex, cross-functional teams
• Excellent oral and written communications skills in English
• Assess Computerized System networks and summarize the essentials in a format understandable for a variety of stake-holders with very different backgrounds
• Ability to work independently and in a team environment
• Excellent communication, negotiation and influencing skills
• Previous experience or training in Computerized System validation and auditing for the pharmaceutical industry
• Experience in working with numerous and diverse stake-holders in a complex matrix environment
• Understanding of latest industry, technology, and regulatory trends
• Skills and experience in managing multiple concurrent projects in matrix organizations
• Experience of managing external suppliers

Project Manager - Implementation - SAP

• Managed projects per SDLC Agile and Waterfall methodologies and procedures
• Facilitated and monitored Sprint Planning, Daily Standups, Sprint Reviews, Team Retrospectives, and Backlog Grooming
• Managed the implementation, requirements, and validation/testing of the systems
• Developed, maintained, and monitored project plans/schedules, metrics, dashboards, and scorecards
• Prioritized, monitored, and reported project progress against planned objectives and success criteria
• Identified, mitigated, and reported risks, issues, and scope changes to sponsors and stakeholders
• Managed project planning and scoping activities, including defining approach, dependencies, risks, and team structuring
• Integrated project tasks, deliverables, and resources into project plans/schedules using effort-based planning
• Made project-level decisions, managed track team leads, and monitored day-to-day team activities
• Collaborated with business and IT partners to define business drivers, information needs, and program goals
• Collaborated with business, IT, and quality organizations to identify system and process impacts
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance
• Managed and provided business, technical, and regulatory compliance guidance to all members of project team

Quality Assurance (QA) Manager / Validation Manager

• Managed the data migration and validation/testing of the system
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards
• Prioritized, monitored, and reported project progress against planned objectives and success criteria
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders
• Participated in business process analysis/mapping workshops for the development of future business processes
• Participated in requirement definition/gathering workshops for the development of business requirements
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs
• Managed and provided business, technical, and regulatory compliance guidance for SDLC/validation deliverables

Validation Analyst/ Quality Assurance (QA) Manager

• Managed large-scale projects per PMO and SDLC Agile and Waterfall methodologies and procedures
• Managed the implementation, qualification/testing, and release of the infrastructure environments/components
• Developed, maintained, and monitored project charters, project plans, metrics, dashboards, and scorecards
• Prioritized, monitored, and reported project progress against planned objectives and success criteria
• Identified, mitigated, and reported risks, issues, and scope changes to steering committee, sponsors, and stakeholders
• Managed risk activities, including risk analysis, mitigation, resolution, and acceptance
• Managed and provided business, technical, and regulatory compliance guidance to all members of the project team
• Reviewed validation deliverables for compliance to 21 CFR Part 11, corporate policies, and SOPs

Analyst

• Monitored the testing conducted by QA dept. and documented the Validation Summary Reports.The project at Medimmune mainly involved working on Regulatory applications
• Involved in coordinating the approval of IT for Insight Publisher Upgrade through authorized Request for Change- RFC
• Co-ordinated with Regulatory Operations to open a new Validated System Change Request in TrackWise to document the implementation of Insight Publisher Upgrade
• Drafted the Installation Qualification Protocol (IQP) as per release notes provided by for implementation of insight Patch
• Involved in review, update and pre-approval of IQP and OQP by uploading the documents in Aegis EDMS involving System Owner, Validation, Information Technology, and Quality Assurance
• Involved in the post execution documentation (as per GDP) of executed IQP, and OQP and coordinated with System Owner, Validation, Information Technology, and Quality Assurance for post approval
• Assured that the VSCR (TrackWise) and RFC (SharePoint) are in appropriate status to ensure IT Compliance as per Medimmune standards to comply with FDA regulations