Sumanth Anapalli
Lake Zurich,IL
Summary
Over 20 years of experience in Information Technology working as Quality Reviewer/Validation Analyst/Business Analyst/ Validation Lead with extensive experience in validating computer applications in regulated companies.
Experienced with QA and Validation of CAMSTAR (MES), Polarion, Salesforce, SAP ECC 6.0, S/4 HANA, LMS, ENOVIA, Compliancewire (LMS), Teamcenter Unified (PLM), Documentum, Siebel CRM, SCORE, ETQ, AGILE (PLM), SMPlus v3.30, Regulatory Change Control System, FSM (Service Management), Reliance (CAPA, Complaints and NCR’s), Labware LIMS, Business Risk Management system, Trackwise, EDMS, Complaint Management System, Laboratory Systems and Web Applications.
Proficient in all the phases of SDLC Process (Software Development Life Cycle), Validation Methodologies and concepts of IQ/OQ/PQ. Experienced with Agile approach in Computer system Validation. Experienced with Data Migration efforts involving high volumes of both Structured and unstructured data. Experienced with Part 11 Assessment and remediation of GxP applications. Expertise in quality documentation review with attention to details.
Developed and reviewed validation deliverables Master Validation Plan, Validation Strategy Document/Validation Plan, User Requirement Specification, Functional Requirement Specification, Design Specification, Risk Analysis, Operational/Performance/Installation Qualification Test Plans, IQ/OQ/PQ Test Scripts, Traceability Matrix, OQ/PQ Summary Reports and Validation Summary Report. Interacted with clients and prepared Business Process Procedures (BPP s), Use Case Diagrams and Workflows in MS Visio.
Wrote/Revised Standard Operating Procedures (SOP s) for validation of computer systems. Strong experience in various types of testing as GUI, functional, regression, integration, system and performance testing for client-server & UNIX applications.
Experienced in the Testing/Quality Tools HP Quality Center. Excellent planning, implementation, and technical background with over 10 years’ experience encompassing the complete lifecycle of a project design, development, testing, validation, deployment and support with strong focus Quality Assurance and Validation in Pharmaceutical and Life science industry.
Overview
20
20
years of professional experience
Work History
Associate Director of Quality and Compliance
Compliancegroup
11.2022 - Current
- Lead the development, implementation and maintenance of quality assurance systems to meet Regulatory and Organizational standards
- Oversaw audits, inspections and assessments to ensure adherence to Quality protocols
- Identified potential compliance and quality risks across processes, products, or services
- Developed strategies to mitigate risks, ensuring that quality and compliance standards are consistently met
- Lead and managed teams responsible for quality assurance and regulatory compliance functions
- Provided coaching, training, and mentoring to ensure that team members are well-equipped to perform their duties
- Promoted a culture of continuous improvement in quality management processes across departments.
Quality and Compliance lead
LS Solutions Inc
07.2021 - 10.2022
- Lead the remediation of Enterprise level systems at multiple clients
- Lead Validation projects at multiple clients
- Assess the validated state of the systems and strategize the remediation effort
- Involved in training and mentoring in Computer system validation process
- Involved in performing data integrity assessments and remediate the gaps identified
- Drafting and review of Procedures, Work instructions and Forms.
Software Quality Assurance Engineer
Abbott Laboratories, IL
IL, USA
05.2019 - 06.2021
- Collaborated with cross-functional departments and teams developing, improving and implementing scalable effective systems that ensure products and services meet customer needs and quality and regulatory requirements
- Provides leadership in the definition, implementation, training and continuous improvement of the quality management system (QMS)
- Worked with internal customers, user groups, and key stakeholders, to create business requirements, quality plans, and deployment of automated electronic systems and applications and modules, that support the corporate quality management system
- Resolved data and documentation quality issues
- Monitored the data management issues as part of data integrity initiative
- Organize and monitor the implementation of validation activities for global systems, ensuring the requirements are being met, and reviewing and approving validation deliverables.
Quality and Compliance lead
Tosoh Bio sciences
12.2018 - 04.2019
- Lead the remediation of Enterprise level systems in a Manufacturing site
- Assessed the validated state of the systems and strategized the remediation effort
- Involved in training and mentoring of onsite staff in Computer system validation process
- Review and Approval of all Computer system Validation specific deliverables and Procedures
- Assisted in drafting and review of Procedures, Work instructions and Forms.
Validation Lead
Baxter Healthcare Inc
12.2014 - 11.2018
- Lead the Computer Validation activities within a project or multiple global projects with medium to high complexity
- Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system
- Manage all validation documents in the project
- Authored Validation Plan, Training Plan, Issues Log, Design Review, Risk analysis, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Trace Matrix, and Validation report
- Reviewed Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records
- Managed Test Case and Test incident creation
- Gathered CSV metrics for reporting purposes
- Oversight of protocol execution
- Managed the overall protocol execution process, including resource management, scheduling/timeline management, incident management, and status reporting
- Lead the Migration and verification of high volume structured and unstructured data
- Prepared documentation within a validation package per policy and procedure to support the validation of an application/system
- Participated in the development of internal CSV training materials
- Managed Validation Analysts activities within a project
- Participated in CSV effectiveness and improvement initiatives
- Participated in CSV knowledge development.
CSV Lead, World Wide Windows 7 upgrade effort
DePuy Synthes
08.2013 - 11.2014
- Worked with CSV reps to identify the list of GxP applications that must be included in scope of Windows 7 project and assist in approval of test scripts to be executed
- Created WW Compliance Plan
- Work with GxP application owners to prepare a detailed deployment plan
- Monitoring progress of GxP Applications
- Provide assistance in pre and post approvals of test scripts for applications
- Guide the Business teams in change control process
- Create WW Compliance Report listing all CR’s executed as part of windows 7 project.
Quality Reviewer- Consent Decree Initiative
Terumo Cardiovascular systems
08.2011 - 07.2013
- Involved in performing a GAP assessment on legacy systems validation package to verify whether or not the system was adequately validated to meet its intended use
- Actively involved in Requirements gathering process
- Reviewed User and Functional Requirement specification documents
- Conducted software Risk analysis per internal procedures
- Reviewed all the validation deliverables (CAF, Val Plan, Risk Analysis, URS, FRS, Traceability Matrix & Validation Summary Report)
- Conducted Electronic Record and Electronic Signature assessment
- Reviewed and approved pre and post executed test scripts
- Reviewed IQ Summary documents
- Reviewed OQ and IQ Protocols
- Managed and reviewed Dry runs and execution of IQ/OQ test scripts.
Senior Quality analyst
Genentech Roche, CA
CA, USA
07.2010 - 08.2011
- Actively involved in Change control process by participating in the CCB meetings
- Involved in streamlining the Quality/Validation activities
- Conducted CFCA (Component Functionality Criticality Assessment) and PHA (Preliminary Hazard Analysis) as part of monthly SAP Maintenance and Enhancement releases
- Reviewed and approved Functional and Technical Specification documents
- Reviewed and approved FRS documents
- Reviewed and approved pre and post executed test scripts for SAP functionality including interfaces with MES system
- Involved in releasing the transports into production using Solution Manager
- Prepared IQ Summary documents
- Authored OQ and IQ Protocols
- Managed Dry runs and execution of IQ/OQ test scripts
- Authored Traceability Matrix
- Authored Qualification Summary Reports.
Senior Quality analyst
Gilead Life Sciences, CA
CA, USA
02.2010 - 07.2010
- Review and approve documentation including corrective actions during validation or testing
- Review SDLC documentation from Requirements to Production deployment from a validation standpoint
- Ensure that SDLC activities within each environment (development, QA, Production) are completed and documented as required by the project or by the approved change request before continuing to the next deployment stage (e.g
- Development to QA)
- Identify issues or deviations from SOP’s, Validation protocols or validation plans
- Review and approve solutions in resolving and closing issues or deviations
- Assess and approve change requests ensuring that impacts of the changes are mitigated and required deliverables are identified
- Assisted in developing a validation strategy to validate Site Recovery Manager
- Coordinated with System Managers and Administrations and prepared a protocol execution Strategy.
Senior Validation/Quality Analyst
MediMedia Inc, PA
PA, USA
01.2010 - 02.2010
- Reviewed and updated the Validation plan for Seibel call center upgrade project
- Created Test Plan to strategize the testing approach, test cycles and roles & responsibilities
- Prepared OQ test protocols for SR fulfillment, SR Contact Opt-out, SR-Medical enquiry, SR- Shipping complaint, SR-Rebate enquiry, SR-PAP, SR-Lookup, Warm transfer-successful etc processes
- Prepared deviation forms and was actively involved in resolution of deviations
- Developed Validation Summary Report and Go live Memo to issue the system for production use
- Trained users on good documentation practices.
Senior Quality Analyst
Integra Life Sciences Corp, NJ
NJ, USA
10.2009 - 12.2009
- Provided direction to the project team members in the development, implementation, upgrade and retirement of systems for quality compliance with regulatory and the business
- Served as a knowledge base for quality compliance with regulatory and the business
- Developed Validation Plan for Canon ImageWare system to be implemented in multiple sites
- Gathered requirements from the business users and developed User Requirement Specification (URS) document
- Updated Configuration Specification document to reflect all configuration elements
- Created Test Plan to strategize the testing approach, test cycles and roles & responsibilities
- Prepared Installation Qualification and Operational Qualification test protocols, test scripts and Test Summary report
- Prepared Deviation forms for all deviation occurred during test execution and followed up with the team for resolution and re-execution of test scripts
- Reviewed business SOPs and updated them
- Developed Validation Summary Report and Go live Memo to issue the system for production use
- Actively participated in UAT to set up necessary test data and train users on good documentation practices
- Reviewed and Updated Test Plan, Val Plan for Trackwise system
- Developed and executed test scripts for Trackwise Change Management system.
Validation Analyst
Wyeth Pharmaceuticals, PA
PA, USA
09.2008 - 10.2009
- Responsible for understanding business requirements and incorporating in Test Scenarios and Test Scripts
- Authoring and executing regression testing and Validation IQ (Installation Qualification) and PQ (Performance Qualification) test scripts for Documentum
- Perform a variety of testing activities such as Unit Testing, Integration Testing, Functional Testing, Performance Testing, and Validation
- Report and track defects in defect management tools such as eRoom in Documentum and Bugzilla
- Worked on SAP Portal and Documentum5.3 to create Web Request for the controlled document workflows
- Authored Documentum (EDMS) scripts in DCM life cycle and workflows
- Coordinate with Project Manager, Requirements Manager, Developers, and Business/Test Analyst to setup the Pre-Validation and Validation environment to execute scripts
- Develop and analyze Test Scripts to check functionality of the application for 21CFR part 11 compliance
- Involved in Execution of the Test Script and writing Test Script Summary report
- Worked as Test Coordinator during Execution of the scripts
- Review and develop the Standard Operating Procedures (SOP’s) for different functionalities and areas of compliance
- Involved in validation of SAP ECC 6.0 rollout project for multiple sites in implementing Supply Chain, Order to Cash, HR, LSO functional modules
- Validated content authoring, content management, and learning management functionality as part of SAP LSO system
- Reviewed and approved test scripts for SAP roll out project prior to test execution as well as post test execution as part of OQ
- Prepared Master Test Plan to strategize the testing approach, test cycles and test deliverables
- Developed IQ and OQ test plans as part of validation of SAP ECC roll out project
- Prepared and tracked Deviation reports generated during OQ test execution
- Developed Validation Summary Report (VSR)
- Attended walkthroughs and meetings with other team members and management.
Senior Validation Analyst
Bristol-Myers Squibb, NJ
NJ, USA
01.2008 - 07.2008
- Developed functional test scripts for SAP R/3 upgrade implementation in accordance with Functional Requirement Specification (FRS)
- Executed SAP functional scripts as per established guidelines and standards
- Actively involved in Integration testing of SAP and Documentum
- Reviewed the workflow SAP test scripts
- Involved in Dry Runs to ensure the test scripts were written accurately for Validation testing
- Performed Unit/Integration/Functional testing and provided documented evidence per regulatory requirements
- Followed established change control process per SOPs to resolve any issues in the testing process
- Developed Technical Specifications and Configuration Object Elements documents as part of SDLC documentation.
Validation Analyst
Wyeth Pharmaceuticals, PA
PA, USA
05.2004 - 12.2007
- Involved in validation of Enterprise Labeling Information system and its interface to SAP R/3 system, including developing Validation Deliverables needed by the company policies and FDA regulations
- Prepared Validation Road Map to update the status of all SDLC documentation
- Prepared 21 CFR part 11 and GxP assessment checklists for electronic records and electronic signatures to verify Audit Trail, Security, and Authority Checks
- Involved in meetings with users to develop Business Process Procedure (BPP) and User and Functional Requirement Specifications (URS & FRS)
- Wrote/ Executed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Prepared Test Summary Report, including summary log, deviation log, signature identification sheet etc., to describe the validation activities performed during the test phase of SDLC
- Involved in Change Control process to change the programming code in validation instance of ELIS
- Developed Validation deliverables that are required by SDLC policy and FDA regulations
- Wrote Standard Operating Procedures (SOP’s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations
- Developed Traceability Matrix to keep track of relationship between requirements and test scripts
- Prepared/Reviewed all the SDLC documentation in accordance with cGMP regulations to verify the quality of the system and documentation
- Involved in validating Inbound and Outbound interface between SAP and ELIS
- Developed validation documentation, such as validation plans, test plans, and summary reports
- Involved in validating SAP implementation which included MM, SD, PP, WM, and QM modules
- Developed the validation/test strategy to implement the interface between LIMS and SAP systems via QM-IDI interface to upload the test results into SAP
- Involved in reviewing SAP audit report that outlines the audit process, identifies deviations from approved SOPs, identifies areas posing risk, and makes specific recommendations for improving compliance profile
- Developed unit and integration test plans, reviewed test results, and generated test reports
- Reviewed and approved functional test scripts prior to and after test execution as per SOP requirements
- Prepared Standard Operating Procedures based on manufacturer's information and documentation, regulatory requirements, and industry standards
- Validated the modified interface programs to LIMS for electronic record trial to comply with the CFR regulations
- Developed Traceability Matrix to keep track of relationship between Requirements, Design Specifications, and Test Scripts
- Prepared Deviation Reports in documenting the deviation as part of validation and its proposed resolution
- Worked closely with SAP Subject Matter Experts to evaluate any design issues and test deviations.
Education
Bachelor of Engineering (B.E) - Electronics and Instrumentation
Madras University
INDIASkills
Validation: IQ, OQ, PQ, Gap Analysis and Remediation, Audit Objectives and Scope, Validation Plan and Protocols, Configuration Management, Traceability Matrix, Risk Analysis, SOP documentation
Regulatory: FDA Regulations, ER/ES - Electronic Records and Signatures (21 CFR Part II), GAMP, 21 CFR 820, 21 CFR 210 & 211 GMP, 21 CFR 50 and 56 GCP and 21 CFR 58 GLP Requirements
Testing: Test protocol design, SDLC, Requirements Analysis, Test Plan Development and Implementation, User Acceptance Testing, Regression Testing, System Testing, Integration Testing
Timeline
Associate Director of Quality and Compliance
Compliancegroup
11.2022 - Current
Quality and Compliance lead
LS Solutions Inc
07.2021 - 10.2022
Software Quality Assurance Engineer
Abbott Laboratories, IL
05.2019 - 06.2021
Quality and Compliance lead
Tosoh Bio sciences
12.2018 - 04.2019
Validation Lead
Baxter Healthcare Inc
12.2014 - 11.2018
CSV Lead, World Wide Windows 7 upgrade effort
DePuy Synthes
08.2013 - 11.2014
Quality Reviewer- Consent Decree Initiative
Terumo Cardiovascular systems
08.2011 - 07.2013
Senior Quality analyst
Genentech Roche, CA
07.2010 - 08.2011
Senior Quality analyst
Gilead Life Sciences, CA
02.2010 - 07.2010
Senior Validation/Quality Analyst
MediMedia Inc, PA
01.2010 - 02.2010
Senior Quality Analyst
Integra Life Sciences Corp, NJ
10.2009 - 12.2009
Validation Analyst
Wyeth Pharmaceuticals, PA
09.2008 - 10.2009
Senior Validation Analyst
Bristol-Myers Squibb, NJ
01.2008 - 07.2008
Validation Analyst
Wyeth Pharmaceuticals, PA
05.2004 - 12.2007
Bachelor of Engineering (B.E) - Electronics and Instrumentation
Madras University