SUMMARY:

• 18+ years’ experience as a Computer System Global Quality Manager, Project Manager, Pharmacovigilance (Research & Development) implementation lead, Validation Manger, CSV Lead, Business Analyst in US, and 10+ years global (India) experience in regulated Pharmaceutical, Life Science, Health Care, Medical Device and Insurance Industry with strong understanding of regulatory expectations, computer system validation, electronic records/ documents and electronic signatures.
• Experience in Company merger in FDA regulated environment with good understanding of regulatory compliance cGxP (cGMP, cGDP, cGAMP, cGLP), CVS, Sarbanes - Oxleystandards and all areas of compliance and governance including: Project risk and impact management and SDLC, Sarbanes-Oxley, Information security, Privacy and Project/Change Management, all aspects of project delivery from and IT Risk and Impact Assurance perspective including; appropriately scoping projects for compliance impact, risk to business, ITRA resource requirements.
• Expertise in approving, authoring, executing and reviewing all documentation pertaining to the software development life Cycle (SDLC) for Quality & Compliance in FDA regulated industry, strong knowledge of FDA guidance’s and industry standards (i.e., GAMP), GMP requirements, FDA/EU regulations and the ability to interpret and apply them.
• Expertise in co-coordinating between Top Management, Program Managers, Project Managers, Systems Developers and Business Sponsors for project implementation, Effective at conducting meetings and brainstorming sessions with excellent meeting facilitation and project management skills.
• Excellent management skill, critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrixed environment and as a Team player can work in conjunction with testing and anomaly management of complex scenarios, development and other teams in validation and Testing & Anomaly management complex scenarios and projects and in the maintenance of Quality Standards in Projects.
• Ability to work on abstract problems across functional areas of the business, Communicating the business requirements, goals, and directives to the technical team and serving as client interface for managing user expectations and achieving client satisfaction.
• Strong verbal and written communication skills, able to work as a team player, lead a team/remote teams or accomplish tasks with high level of accountability without supervision, and support several changes/projects simultaneously on multiple projects with hands on experience in HP Quality Center.
• Strong knowledge of Segregation of Duties (SoD).

CHRONOLOGICAL EXPERIENCE:

Confidential

Project Quality Manager (Consultant)

Responsibilities:

• As the Project Quality Manager managed complex, cross-functional, multi-site, global projects and work streams, coordinated interactions ensuring timely and optimal execution of the plans, Track financials of the project, ensuring accurate projections and needs coordinate stakeholder assessments and management of stakeholders/sponsors.
• Collaborated with manufacturing site Project Management Offices (PMOs) and external vendor’s service providers, 3rd party vendor and in-house developers to deliver key objectives of the program/project(s) for effective project planning and portfolio management.
• Coordinate and manage project meetings and communications Identify and manage risks and issues, work with the IT business partner to in corporate business strategy, project team (Quality/Technical/Developer/Test), clients and other stakeholders to develop strategies to mitigate risks as appropriate.in direction to clearly define any upstream/downstream interdependencies.
• Assist informatics team and project sponsor in executing a communication and change management strategy in support of project execution and rollout
• Oversee and supported the planning of strategic initiatives and executed strategic projects, including completeness of documentation and appropriate access for required stakeholders, support for end-to-end optimization including development, execution, sustain, and improve Validation systems, comprehensive change management, effective technology and disciplined project prioritization as defined by the Confidential Information and Governance Management (IGM) to ensure compliance with FDA regulations/guidelines and regulatory requirements.
• Supported the Regulatory Team and Business team, including use of appropriate tools and templates for consistency and accuracy, including leveraging team SharePoint collaboration site with consistent tracking and reporting throughout the project in line with PMO best practices, monitor and report project charters, progress against project plans, and communicate status to key stakeholders ensuring adherence to plan and strategy, escalating delays, scope changes, and resource constraints.
• Prepare and manage periodic status reports for project team, steering committees, Team and Tollgate meetings while addressing key issues and actionable items leading the team projects as assigned, responsible for identifying, facilitating resolution of and escalating issues as well as tracking and communicating progress and results within the team, identify trade-offs for conflicts and facilitate decision-making within the team. Identify resource gaps and needs to execute the project and operationalize the system into a support state, oversee all QA & training activities to ensure smooth delivery
• Frequent overnight travel to Bangalore (India) & Hyderabad (India), Basel (Europe) global project meeting sites and facilitated support between site and HQ for high performance teamwork and maintained strong relationships with and across global organization (e.g., operations, manufacturing technology, quality, supply chain, finance, R&D) leaderships. with all additional duties as assigned to enable development and execution of realistic plans, while taking considered risks and driving decisions, identified issues/opportunities and lead contingency planning, assumptions change, drive scenario analyses to manage potential impact on plans and timelines to overcome critical milestones and accomplish planned results in a timely manner ensuring compliance against all applicable procedures and regulatory requirements within the project, understand and endorse general quality management principles for applications, upgrades, enhancements to existing applications listed below using formal SDLC practices and Agile methodologies:

Confidential

Quality Pharmacovigilance (Research & Development) implementation Manager (Consultant)

Responsibilities:

• Established and enforced quality assurance measures, testing standards for applications, upgrades, enhancements to existing applications listed below:
• MedXview eCentral eCTD System Version 3.2.2.6(
• MasterControl™ Application Suite Version 11.2
• Document Module,
• Training Module,
• Portal Module and
• Process Module.
• MasterControl™ Application Suite Version 10.1.3
• ExcelSafe Version 2.1
• SAS - Content Uniformity & Dissolution Acceptance Limits (CuDAL) Version 2
• Minitab Version 17
• TotalChrom Version 6.3.2
• FactoryTalk Water Backup and Reporting System
• BACKTRACK System Version 2012.0.3
• AmegaView Monitoring System
• Recruited resources and trained on boarding talent for both short and long term and managed resources across many projects and demands maintaining close communication with team members to keep apprised of computerized project validation status, and other relevant issues
• Created templates and SOPs for merger, best practices, policies and procedures, Facilitate the Computer system validation Risk and Impact Assessment to identify governing regulations and validation deliverables during the development of the computer system and application retirement ensuring that Internal Systems and Methodologies meet or exceed FDA requirements as they pertain to cGCP 21 CFR Part 11 Compliance for electronic submissions to regulatory agencies.
• Defined strategic direction and roadmap for quality and testing throughout the lifecycle of the Pharmacovigilance FDA Adverse Event Reporting System (FAERS) including but not limited to project scope, quality, and timeline in conjunction with software deliverables.
• Review computerized systems validation deliverables such as Project Plan, CSV Risk and Impact Assessment, Validation Plan, Business Impact Analysis, Requirement Specification, Design and Configuration Specification, Application Installation qualification Protocols, Operational Qualification Protocols, Performance Qualification protocols, Data Migration Protocols, and their respective Summary Reports, Traceability Matrix,, Release for Use Memo, Risk and Impact Assessment, Testing & Anomaly management, Defect logs, Deviation logs, Validation Summary Reports for various projects
• Assist in implementing integrity of the data and the system to stay in compliance with the FDA standards (21 CFR Part 11, 210, 211, 820), create/update SOPs and training plan as and when needed.
• Assess compliance practices and draft recommendations for corrective action to support creation and maintenance of compliance processes and standards
• Organize validation documentation and assist project audit readiness for internal & external and FDA audits.

Confidential

Computer System Quality Validation Manager (Consultant)

Responsibilities:

• Managed the responsibility for Author/Review of computerized systems validation deliverables ensuring any Change request or enhancements for existing validated websites and systems like MDM, OTC-SAP such as CSV Risk Assessment, Risk mitigation, Validation Protocol, User Requirement Specification, Functional Requirement Specifications, Detailed Design and Configuration Specification, Operational and Performance Qualification Protocols, System test Scripts (pre executed and post executed) in HPQC version 9.2, 10.0 and for manual execution, Operational and Performance Qualification Summary Reports, User Acceptance Test Protocol, User Acceptance Test Scripts, User Acceptance Summary Report, Traceability Matrix, Promote to Test/Production code verification, Release for Use Memo, Defect logs, Developed the Deviation documenting template, Validation Summary Reports, Problem Reports, Create status reports, Change control reports, for various small to medium size projects and/or components of larger projects met the quality standards and its respective FDA regulation in the planned timely manner. Organize validation documentation and prepare for archival and or FDA audits.
• Managed as a Quality System Compliance and Validation Lead and/or as a project manager for the entire implementation of start to end entire new validated system (TRIM Version 7.3.4) implementation impacting 100+ Users across multiple domains. Authored/Reviewed/Approved various SDLC deliverables either by formal SDLC practices and Agile methodology like Compliance Risk and Impact Assessment, Compliance Plan, Request for Change Control Form, Business Impact Analysis, User Requirement Specification, Architecture Design, Functional Design Specifications, Database design, Master test Plan, Functional Phase Exit Review Check List, Security Configuration Standard, Technical Design Specifications, Data Migration Test Protocol, System test Protocol, Data Migration Scripts (Pre and Post Approval in HPQC version 10.0), Data Migration Report, System Test Scripts (Pre and Post Execution Approval in HPQC version 10.0), Production Verification Test Scripts (Pre and Post Approval in HPQC version 10.0), Technical Phase Exit Review check list, System Test Report, User Acceptance Test Protocol, User Acceptance Test Scripts (Pre and Post Execution in HPQC Version 10.0), User Acceptance Test Report, Master Test Report, Traceability Matrix, production readiness check List, Code Promotion (Test Environment and Production Environment) Compliance Report, Change Control Report, Hyper care, Training of New System, Decommissioning of the Older system, Standard Operating Procedures and Work Instruction for the new System.
• Maintain close communication with team members to keep apprised of computerized project validation status, and other relevant issues, create/update SOPs and Compliance Wire training as and when needed, Assess compliance practices and draft recommendations for corrective action and Maintain a working knowledge and awareness of regulatory requirements with the team, train new team onboarding members on creation, execution, and review of CSV documents.
• Coordinated with various groups of the website to successfully retire the Internet based web application ensuring that Internal Systems and Methodologies meet or exceed FDA requirements as they pertain to cGCP 21 CFR Part 11 Compliance.
• Performed the World Wide Internet Compliance Office (WICO) annual periodic review for existing multiple websites. Reviewed and guided the business owners for Business Case Summary Report for existing multiple websites maintain a working knowledge and awareness of regulatory and WICO requirements.
• Created metrics for Q&C activities like Change Control and SDLC activities, resource management, and Budget management. Analyze data and make recommendations based on findings as and when needed.

Confidential

Information Management Quality Assurance Computer System Validation Manager (Consultant)

Responsibilities:

• Lead the Development, establishment and enforcement of quality assurance measures, Testing & Anomaly management for new applications, products, upgrade and/or enhancements to existing applications listed below:
• CallMax
• Clinical Trial Management System(CTMS) ECLIPSE 1.0
• Condor Retirement eDM( Electronic Data Management) 3.3.3 21 CFR Part 11 Verification
• LIMS Sample Manager
• MDM
• Mercury Quality Center Release 9.2
• OmniRIM
• Compliance Wire (LMS)
• Plateau 5.5
• Plateau 6.1
• ROBAR
• SAP Solution Manager (Release 7.0)
• SMRS (Release 5.0)
• SMRS (Release 5.2)
• STAT
• TrackWise QMS Version 6.0 ( June 2010 Release)
• TrackWise QMS Upgrade (Version / Release 8.2)
• TrackWise QMS Enhancements (Dec 2011 Release)
• Follow SOPs and company best practices, policies and procedures, Facilitate the Computer system validation Risk and Impact Assessment to identify governing regulations and validation deliverables during the development of the computer system and application retirement ensuring that Internal Systems and Methodologies meet or exceed FDA requirements as they pertain to cGCP 21 CFR Part11 Compliance
• Define the strategic direction and roadmap for quality testing & anomaly management throughout the lifecycle of the project. Analyze the documentation and technical specification for any new application under deployment or consideration to determine its intended functionality. Conduct internal audits to measure and assure adherence to established QA standards for software development, application integration, and information system performance, and corresponding documentation. Coordinate testing of software to ensure integration of functional requirements, system compliance and technical specifications.
• Recruited resources and trained on boarding talent for both short and long term and managed resources across many projects and demands maintaining close communication with team members to keep apprised of computerized project validation status, and other relevant issues.
• Assist in planning, implementing, and documentation related to project Provide guidance on quality issues that affect the integrity of the data or the system to stay in compliance with the FDA standards (21 CFR Part 11, 210, 211, 820), create/update SOPs and training plan as and when needed.
• Assess compliance practices and draft recommendations for corrective action to support creation and maintenance of compliance processes and standards
• Maintain a working knowledge and awareness of regulatory requirements, coach project teams where significant risks and compliance issues are involved, including those that have not been encountered before and/or have broad implications for the business,
• Organize validation documentation and prepare for Quality, Internal Audit & business associates to ensure project audit readiness for internal & external and FDA audits.

Confidential

Validation Project Manager

Responsibilities:

• Perform project management functions for transfer of Quality Systems.
• Lead activities pertaining to Deviations, CAPA, Change control, Documentation, Training systems, Complaints, Release, etc.
• Lead activities for readiness for FDA inspection for QA and laboratory operations.
• Communicate applicable regulatory requirements of 21 CFR 210 and 211 cGMPs
• Lead and facilitated multidepartment/multifunction meetings
• Maintained and tracked project plans, spreadsheets and Gantt charts related to the project, prepared metrics and presentations of report status of various stages of the project.
• Derived project timelines with responsible individuals to ensure timelines and overall project is delivered on time.
• Lead and participated in requirements gathering sessions with client business and IT personnel. Plan, Lead conduct, document, and direct the analysis of complex business problems and processes. Translate business requirements to functional requirements, Develop and implement business process flows, Meet with the business subject matter experts to ensure requirements meet expectations, Facilitate discussions between the various technical groups and Business user groups making teamwork and collaborative skills essential.
• Lead Testing & Anomaly management the application to ensure that it meets all functional requirements (Traceability Matrix), Support planning of user acceptance test (UAT), including creation of UAT scripts. Define training approach and assist in the development and delivery of training materials.
• Assist in development of validation/systems compliance training on systems compliance initiatives; provide continuing compliance education support to the Global IT Organization.
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Prepare computerized systems documentation such as Validation Plan, CSV Risk and Impact Assessment, Test Plans, Test Summary Reports, Test Scripts, Traceability Matrix, and Validation Summary Reports.
• Develop, execute and manage computer validation activities in accordance with company policies, standards and regulatory expectations; includes preparation and review of validation and qualification protocols, analysis of data, and preparation and review of validation and qualification summary reports and ensure traceability of functional requirements, risk assessment through validation testing & anomaly management.
• Assist in establishment of internal company documentation (SOPs). Organize validation documentation for archival and draft recommendations for corrective action. Support internal IT Change Control procedures; provide quality systems review of applicable changes.
• Coordinate project activities with Validation Specialist to ensure quality assurance activities and documentation are in compliance with company standards. Assist in developing implementation of documentation of project plans and status reporting. Assist analyst in translating business requirements to vendor design.

Confidential

Regulatory/Compliance/Validation/Project Manager

Responsibilities:

• 17+ years’ experience as a Computer System Quality Manager, Project Manager, Validation Manger, CSV Lead, Business Analyst in USA, and 10+ years global (India) experience in regulated Pharmaceutical, Life Science, Health Care, Medical Device and Insurance Industry with strong understanding of regulatory expectations, computer system validation, electronic records/ documents and electronic signatures.
• Experience in Company merger in FDA regulated environment with good understanding of regulatory compliance cGxP (cGMP, cGDP, cGAMP, cGLP), CVS, Sarbanes-Oxleystandards and all areas of compliance and governance including: Project risk management and SDLC, Sarbanes-Oxley, Information security, Privacy and Project/Change Management, all aspects of project delivery from and IT Risk and Impact Assurance perspective including; appropriately scoping projects for compliance impact, risk to business, ITRA resource requirements.
• Expertise in approving, authoring, executing and reviewing all documentation pertaining to the software development life Cycle (SDLC) for Quality & Compliance in FDA regulated industry, strong knowledge of FDA guidance’s and industry standards (i.e., GAMP), GMP requirements, FDA/EU regulations and the ability to interpret and apply them.
• Expertise in co-coordinating between Top Management, Program Managers, Project Managers, Systems Developers and Business Sponsors for project implementation, Effective at conducting meetings and brainstorming sessions with excellent meeting facilitation and project management skills.
• Excellent management skill, critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrixed environment and as a Team player can work in conjunction with testing, development and other teams in validation and testing and anomaly management of complex scenarios and projects and in the maintenance of Quality Standards in Projects.
• Ability to work on abstract problems across functional areas of the business, Communicating the business requirements, goals, and directives to the technical team and serving as client interface for managing user expectations and achieving client satisfaction.
• Strong verbal and written communication skills, able to work as a team player, lead a team/remote teams or accomplish tasks with high level of accountability without supervision, and support several changes/projects simultaneously on multiple projects with hands on experience in HP Quality Center.
• Strong knowledge of Segregation of Duties (SoD).

Confidential

Quality Analyst

Responsibilities:

• Authored and Reviewed documents for all aspects of the computer systems validation lifecycle, accordance with FDA regulations, particularly 21 CFR Part 11, including Validation Plan, Application Installation Qualification (App-IQ), Performed various testing for Finished products, Raw material, Stability samples, In Process samples, Environmental monitoring, Water samples.
• Performed Risk Analysis, Ensured that programming and testing procedures are addressed and that all scheduling aspects of projects are monitored.
• Guided to create details about each process and modifications to the Global Complaint Handling System (GCHS) that provided appropriate scope of work for technical team to develop prototype and overall system.
• Used the guidelines and artifacts to strategize the implementation of different iterations and phases of the Testing.
• Involved in Change Request meetings to document changes and implemented procedures to test changes.
• Assist in establishment of internal company documentation (SOPs). Organize documentation for archival and draft recommendations for corrective action. Support internal Change Control procedures; provide quality review of applicable changes.
• Coordinate project activities with Validation Specialist to ensure quality assurance activities and documentation are in compliance with company standards. Assist in developing implementation of documentation of project plans and status reporting.