SUMMARY:

• I am a seasoned Computer System Validation professional with over 11 Years of experience in managing multi - disciplinary teams of varying sizes and complex programs of Process Compliance, Quality Assurance, Project Management, Business Process Analysis, Process Framework development, Risk Assessment and Profiling, Process Re-Engineering, Reviews, Audits, GxP, Regulatory Compliance against FDA - 21 CFR Part 11 and GAMP 5.0 Framework in Pharmaceutical / Medical Device IT Compliance & Quality environment.
• Provided consulting solutions globally for top 20 pharmaceutical companies in the Project Management, Computer System Validation and Quality Assurance
• Managed Multi-Million Dollar Projects by developing / scoping project plans, Resource and Budget Planning, execution of assessment / gap analyses and resolution of challenges at hand, maintaining stakeholder communication (detailed and executive summaries), prioritizing project tasks based on risk & effectiveness, developing Progress Metrics, and tracking a dynamic project based on regulatory/management needs
• Worked with Confidential as Senior Principal and consulted for Drug Safety and Pharmacovigilance industry to help manage Adverse Event Reporting
• Set up Validation practice and own Quality Initiatives across the organization
• Well-versed with Data Integrity and ALCOA principles
• Supported project teams at multilevel hierarchy to plan, execute and deliver validation projects with zero flaws and in time delivery
• Governance of Cross-phase procedures and plans like Validation Plan, Incident Management Plan, Change Control Procedure, Document Management Plan, Training Plan, etc.
• Development, Execution, Review and Monitoring of the Qualification (IQ, OQ, PQ, MQ) Protocols, Results and Reports
• Implementation, Execution and Approval of Test plan, Test Procedures, Test Scripts, Test Results, Test Reports and Test matrix for Unit, System and User Acceptance testing phases
• Prepared / Reviewed Requirements Traceability Matrix for the Functional completeness of the systems
• Contribution to the Standard Operating Procedures (SOP) Drafting, Review and Approval
• Apt knowledge of creating and managing workflows and documents in Electronic Document Management Systems
• Conducted Audits for the Offshore Service and Technology Centers and ensured closure and verification of identified non-conformances in customer audit and implemented CAPA
• Provided training and coached various project teams, as required, on relevant project procedures, IT policies, Good Documentation Practices, Good Testing Practices and Confidential basics, whenever needed

• Leading the Quality Core Group with the objective of continuous improvement and process compliance
• Developed the Training kit for Competency building and educated associates to ramp up for Confidential Platform and trained more than 200 employees on Confidential and GxP fundamentals
• Identification of best practices and lessons learnt for cross-pollination
• Developed Process Framework and was involved in development of Confidential QMS for Confidential, Confidential Pharma (after the merger of Confidential Pharma and Ranbaxy), Dynavax and QVAL, Satyam’s Pharmaceutical Quality Management System to comply with life sciences regulatory requirements based on GAMP and industry best practices for validating and maintaining the validated status of IT systems
• Strategized the Prospective / Concurrent Validation approaches for all GAMP Software categories including bespoke GxP applications, Global Site Implementations, Warehouse applications, Pack Management, Laboratory Information Management Systems, Spreadsheets, Infrastructure, Drug Safety applications, Confidential remediation for USFDA, etc.
• Maneuvered the strategy for Configuration Verification of the Drug Safety data
• Data Migration Qualification planning and verification of the migrated data from multiple sources
• Standardization of deliverables and QA processes to increase efficiency and reduce new product / project rollout time by 4 weeks
• Designed the Validation strategy for automated Configuration upload and verification of Drug Safety data which improved the process efficiency by reducing 60% of time taken
• Validated E2B Comparison tool which reduced the time invested in comparing the E2B Reports
• Conceptualized and developed the Validation kit for hosted customers to avoid multiple rounds of OOB functionality testing.
• Contributed to Process Improvement Initiatives resulting into Benefit Delivery plan generating cost savings to customer and organization
• Acclaimed for People Development in recognition of training, mentoring skills and developing Confidential competency
• Managed complex engagements for most of the top 20 Life Sciences Companies
• Prepared Statement of Work (SoW), Project Schedule / Plan, estimations for resources across the projects for validation engagements & tracked through the Project Plans
• Collaborated on client engagement strategy, improved client relationships and project predictability coupled with Stakeholder Management and time-boxed quality delivery

KEY SKILLS:

Primary Skills: Computer Systems Validation, Process Consulting, Validation Compliance

Project Management: Project Planning (MS Project), Progress Metrics and summaries, Resource and Budget Planning, Issue and Risk Management, Stakeholder Communication, Scope Definition and Management, Time Management, Quality Management and Project Integration

Regulatory Compliance Services: 21 CFR Part 11, GAMP 5.0 Framework, GxP

Requirement Management Tool: DOORS, AGILE PLM

Electronic Document Management: AGILE PLM, Controlled Document Management System, Documentum, Master Control

Test Management Tool: Quality Center

Other Skills: Software Quality Assurance, Process Engineering, Process Compliance and Improvement, Metrics collection and generation, Quality Audits, People Development

WORK EXPERIENCE:

Sr. Computer System Validation Consultant

Confidential

Responsibilities:

• Lead validation activities of varying complexity including Enterprise-wide systems and programs
• Plan and execute the retirement of Quality, PreClinical, Drug Safety, Regulatory, Clinical Operations, IT and Biometric computer systems used for GxP activities
• Retirement of the systems under the Change Control including the development of System Retirement Plan, Risk based Impact Analysis, data backup, archival, data migration / conversion and disposal, disabling users and interfaces
• Data Delivery and Migration Qualification to ensure the data disposition from the retired system
• Work collaboratively across functions with Quality Management, IT, Business, Vendors and Consultants to plan, coordinate and execute computer system validation activities
• Oversee team contributions to deliverables, installation activities, testing activities and ensure validation testing is conducted in an appropriate and timely manner
• Provide validation operations support for computer systems used for GxP activities including understanding the business, determining business and system requirements, project planning for validation work-stream, and collaborating with project team members in the development and delivery of validation deliverables
• Author validation deliverables including Validation Plan, User Requirements Specification, Configuration Specification, Design Specification, IQ, Test Plan and Scripts, Traceability Matrix and Validation Summary Report for the projects
• Provide the validation direction to internal and external project team members

Confidential

Responsibilities:

• Validated the computerized systems (e.g. Pharmacovigilance, ERP - Microsoft Dynamics, Serialization and Document Management) and qualified the infrastructure in compliance with client’s Computer System Validation and Qualification Process and Procedures
• Collaborated with client staff to define Business and IT requirements and create Requirements and Specification documents such as User Requirements Specifications, Functional Requirements Specifications and Design Specifications
• Managed the Risk Management process by ensuring that the tests and other controls are in place to mitigate the Risks
• Developed and executed Test protocols such as Installation Qualification, Operational Qualification and Performance Qualification to ensure that the system is configured and installed to meet specified requirements
• Worked closely with IT and functional subject matter experts (SMEs) to determine the content for SOPs, WIs and forms. Participate in review sessions of SOPs, WIs, and forms to in corporate comments and/or changes, as applicable
• Assisted IT and appropriate Business and QA functions with Change Management, Issue Management and CA/PA (Corrective Action and Preventative Action) documentation authoring and execution
• Collaborated with project teams to identify, analyze, prioritize, document and communicate project risks to mitigate impact to project deliverables and timeline

Sr. IT - Specialist

Confidential

Responsibilities:

• Project Liaison / Lead between the Business (end-users), Quality, and the Technical teams to identify the user/ system requirements and manage the project timeline for systems (Documentum, Trackwise, BMC Remedy, BMC BPPM and Arcos)
• Managed the Change Controls for SAP and their associated validation deliverables
• Developed all validation related documentation required to meet the project needs
• Worked closely with the project team to determine the validation approach and provide guidance throughout the project
• Implemented processes/methods to improve efficiency and promoted consistent validation of systems
• Reviewed and approved all Computer System Life Cycle Documentation: Business Requirements, System/ User Requirements, Design Specifications, Unit Specifications, Validation Protocols (IQ, OQ, and PQ), Configuration Specification, IT System Change Controls, Support Plans, Data Migration Plans and User Documentation (SOPs, User Manuals, Training Material, etc.)
• Provided weekly project updates to Project Stakeholders / System Owners

Sr. Principal Consultant

Confidential

Responsibilities:

• Setup Validation practice at Foresight Group - structured Testing team into Validation team and own Quality Initiatives across the organization
• Prominent Confidential Advisory and Consulting character to setup the Confidential environment across the projects / work streams and design the Validation deliverables’ templates / strategies
• Directed Multi-disciplinary teams on quality procedures in Multi-Million Dollar Pharmacovigilance projects for pharmaceutical companies spread across multiple continents using GxP-regulated systems
• Onsite Quality and Validation workshops to strategize the validation approach followed by System and Functional Risk Assessment and Criticality Analysis for requirements
• Project schedule, estimations & tracking by planning for the projects and developing the Project Plans
• Forecasted resource needs and proactively planned for staff acquisition across the organization for validation engagements
• Coordination with the client, managed risks/issues and followed through to closure
• Risk Assessment, Profiling and Mitigation for Business and Regulatory Risks
• Data Migration Qualification planning, Identification of Scenario and finalization of Data Migration strategy and verification of the migrated data from multiple sources
• Maneuvered the validation strategy for bespoke applications designed to perform Configuration Upload, Verification, and E2B Reports comparison of the Drug Safety data
• Harmonization of the Technology, Application, Testing and Data Migration teams for issues related to quality, training and compliance
• Defined Qualification approach for the environments / tools / interfaces associated with the system under validation scope
• Reviews and Inspections of the processes and deliverables to ensure compliance, consistency and comprehensiveness
• Assured that the systems meet the requirements and compliance with SOPs, applicable client policies and procedures, and the requirements of Validation Plan
• Training compliance and audit readiness
• Configuration of Defect Management tools for tracking the project issues
• Conducted Periodic Compliance Audits to assess the health of projects and ensured compliance to processes and standards

Confidential

Project Lead

Responsibilities:

• Confidential QMS Setup and Implementation at Confidential
• Monitored progress of the projects per Project Management Plan, and ensured timely resolution of Business and Regulatory issues to have effective Confidential deliverables
• Inculcated GxP and regulatory input into validation projects with particular focus on quality
• Risk Assessment and Profiling for Business and Regulatory Risks
• Liaison with Domain experts and Senior Project managers for Reviews and Inspections of the processes and deliverables to ensure consistency and comprehensiveness
• Conducted sessions with large groups of individuals consisting of Business Analysts, Subject Matter Experts and Process Owners from cross-functional areas to gather information and complete documentation of “ As-Is” and “ To-Be” business processes
• Interpreted and inculcated the Electronic Record and Electronic Signatures (ERES / RERS) requirements in projects against 21 CFR Part 11 regulations
• Harmonized the teams for issues related to Deviation Management and Change Control Management

Confidential

Quality / Process Lead

Responsibilities:

• Consulted a large Life Sciences Institution for executing Validation activities and advised the Projects on IT related quality issues, regulatory compliance and Client policies and standards relating to IT systems
• Harmonized the teams for issues related to Incident Management and Change Control Management and performed Root Cause Analysis (RCA) on process deviations/Quality issues
• Conducted integrated Quality Management System (QMS), Electronic Document Management System, GxP Overview, Validation Fundamentals, Test Case Authoring, Test Execution and SOP trainings for the project team members
• Re-designed Local Standard Operating Procedures (LSOPs) for Test Case Authoring, Review and Execution
• Monitored the Qualification (IQ, OQ, PQ) and Testing (Unit, System, User Acceptance) to trace and validate the requirements and specifications