Candidates About

 

Chakra Golla   CSCP.PMP

Supply chain management

§   Software Quality Assurance

§    Business Analytics

§ Customer support

§ VALIDATION Regulatory Compliance

·         Results-driven Business Technology executive with over 18 years of business experience including 12 years of IT experience related to operational compliance within a highly regulated industry.

·         Over nine years of Global Supply Chain Management experience with Third party logistics (3PL) companies.  Managed an office with responsibilities for business forecasting, client and business development, customer service, Supply chain improvement, operational compliance planning, and P&L.

·         Supply chain management and vendor coordination for International buying houses for their Global Sourcing Operations from Forecast to Order and Production to Delivery processes. Implemented the Best practices of Collaboration, Groupage, JIT, Synchronizing inbound and out bound Logistics to increase the profitability of the Buying houses.

·         Experienced Professional with Supply Chain processes and systems as well as involvement in Business Process improvement /Change Management consulting and implementation .Identifies issues, and defines actions and solutions to significantly improve results.

·         Highly motivated with solid experience in implementing/managing quality assurance program for CRM, Analytics and ERP solutions across various Life Science industries. Worked on Reports, Dashboards, score cards and Descriptive analytics to report performance management to Corporate management.

·         Ensured the developed and deployed solution meets the end requirements and Quality standards.

·         Used test tools for test tracking, defect management, and test automation.

·         Prepared and reviewed documents for test strategy, risk analysis, gap analysis and test summary reports.

·         Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation.

·         Lead and Participated in test planning, test case creation, analysis and implementation for Sanity testing, Installation testing, Front-End testing, Back-End testing, Integration testing, Full-Cycle testing, regression testing ,  Data-Migration testing  and end user acceptance testing (UAT).

·         Conducted daily and weekly team meetings and updated the status and test metrics to project management.

·         Excellent team player and able to work effectively at all levels of an organization with the ability to influence others to move toward consensus

 

Education & Certification

• B.S in Biology from S V University, Tirupathi, India.
• Post graduate Diploma in Export Management from Institute of Management.
• Project Management Professional (PMP) certified.
• Certified Supply Chain Professional of APICS ( The Association for Operations Management )

 

IT Tools Skills

 

·         ERP environment: SAP (ECC, SCM, PTP, OTC, CRM, BI, MDM) CARS, Oracle JDE E1 and Baan.

·         Software Development Tools:  Quality Center, JIRA, Rational tools and Visual SourceSafe.

·         MS Technologies: .NET, VB Script, Visio. PowerPoint, Word, Excel, Microsoft Project.

·         Others: PDMA, 21 CFR Part 11,DQSA(DSCSA), Computer system validation, SDLC, Oracle, SQL ,Data stage, ODS, Data Mart, Informatica, Business Objects, Mobile Intelligence, EDI, QlikView, Web applications , Analytics,jupyter and FDA compliance.

 

 

 

 

 

 

 

 

PROFESSIONAL EXPERIENCE

 

Deloitte Consulting                                                                                                                                       Jan17 to present

 

 

 

Client: Health care –  Enterprise RevOpt Medicaid Project (Health Care Analytics)

Client is the largest Heath care payor in the U.S. The Affordable Care Act establishes State-based Reinsurance and Risk adjustment programs.

 

Role: As a Testing consultant, was involved in test Planning, test development, test management and test reporting activities.

 

• Preparation of test estimates and schedules for Releases

·   Developing the test scripts and test plan.

• Participate in peer reviews of test artifacts

• Test Execution and Defect Management.

• Work as a liaison between Onsite-Offshore and Clients

Technical Environment: Informatica, DB2, Teradata SQL Assistant, JIRA.

 

Industry:  LifeSciences  Service Area: Technology

Role: System Integration Test Lead months.  8 months

A leadingLifesciences client . This project is Executive Compensation Outsourcing.

Role:

·       Engaged with clients to analyse business requirements

·       Prepared test strategy, test requirements and acceptance criteria documents

·       Creating Test Estimation, Test Scenario Preparation

·       Involved in Test execution, Tracking and reporting defects

·       Mentoring team and managing their deliverables

·       Maintain the Requirement Traceability Matrix (RTM)

·       Creating Test summary report

Technical Environment: SAP HR, ECM, HP QC, Equity compensation Manager, Global Data Warehouse

 

IBM Watson Health Analytics,                                                                                                                                      Aug 16 to Jan17

Role: validation consultant

Project Summary: Validating Watson Health Core for Life Sciences–Foundation(WHCLS-F) cloud Platform-as-a-Service (PaaS) that supports GxP, 21 CFR Part 11, HIPAA, to maintain privacy, security, and record integrity for life sciences customers

IBM Watson Health Cloud for Cognitive Systems of  Life Science applications provide  data storage, data ingestion, data retrieval, data pseudonymization, consent management, platform security, network security, data security and encryption, 21 CFR Part 11 and HIPAA controls, user authentication, role-based access control, scalable infrastructure, high availability, and global data centers.

Key Activities & Responsibilities:

·         Participated in Mapping out the business process.

·         Assisted in developing business documentation ( SOPs, Work Instructions, Process controls, Risk Maps) and business process maps

·         Preparing and reviewing  IQ, OQ and PQ documentation for Regulated application DEA/FDA/HIPAA areas using Rational tools.

 

PAR  Pharma (Endo Group)   ,                                                                                                                                      Feb 16 to July 16

Role: validation consultant

Project Summary: PAR is implementing JDE application for their associate company. The application helps in merging supply chain functions.

Key Activities & Responsibilities:

·         Participated in Mapping out the business process (Manufacturing,  Distribution Center operations, transportation to Wholesaler, Retailer, EDI, ASN,  Work flows and data flows for OTC and P2P .

·         Assisted in developing business documentation (Business Requirements, SOPs, Work Instructions, Process controls, Risk Maps) and business process maps

·         Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation for Regulated application suspicious order management and DEA/FDA regulated areas.

·         Participated  in   evaluating  software package that uses global manufacturing and distribution center data to identify and track products from the manufacturer to the wholesaler and retail customer in concordance with proposed regulations

·         Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory compliance needs.

 

 

Glaxo Smith Kline,                                                                                                        Jun 14 to Dec15

Role: System Tester

Project Summary: To compliance the Drug Supply Chain Security Act (DSCSA) GSK has added systematic controls to specific systems to ensure GSK’s customers have a valid state license for receiving shipment s and can be provided with Transaction Information and Transaction Statement for their transactions.

 

Key Activities & Responsibilities:

·         Supported the implementation of business processes to ensure GSK is compliant with legislative requirements of the Federal Drug Supply Chain Security Act by testing the business processes thru the order management system.

·         Assisted in developing business documentation (Business Requirements, SOPs, Work Instructions, Process controls, Risk Maps) and business process maps.

·         Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation

·         Developed testing plans (UAT, Regression, and Defect Management) for quarterly scheduled Order Management System IT builds for DSCSA compliance. Participated in defect triages, status meetings and updated management about the status.

·         Communicating the customers and stake holders about   DQSA impact to order cycle time.

·         Maintaining  DQSA reporting capabilities , Monitor KPI’s, Process root cause analysis and monthly auditing requirements

• Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory needs.
• Participating in   GS1 Rx Secure Supply Chain discussions and HDMA Traceability Group calls, Third Party Solution Provider webinars and continue to ensure GSK’s T&T Strategy is aligned to larger pharmaceutical industry .Summary will be updated to T&T Manager about the upcoming trends in the trade.
• IT Environment: JD Edwards, CARS,DCMS,EDI ASN 856, DQSA, Quality Center and Rational tools

EIS   Inc          ,                                                                                                               Jan 14 to May 14

Role: Test  Lead

Project Summary: EIS is developing a Customer relation management application for pharma clients to measure their sales force effectiveness and track PDMA regulated activities. The application helps in tracking the sales calls and sample drops of the reps.

Key Activities & Responsibilities:

·         Developed Test strategy, SOPs, test requirements and acceptance criteria documents.

·         Resource planning, Use case preparation, training testers and offshore team management.

·         Conduct functional testing, integration testing, and data migration testing.

·         Coordinated User Acceptance Testing to ensure that the SFA and SAP applications meet the end customers day today needs.

·         Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation for regulatory  compliance

IT Environment: SAP ECC6.0, SFA, Quality Center , Analytics.

 

Glaxo Smith Kline       ,                                                                                                         Oct 13 to Dec13

Role: System Tester

Project Summary: GSK is implementing Track and Trace application for fulfilling California State Product Serialization act. The application helps in tracking and tracing the product with the product id printed on the individual unit.

Key Activities & Responsibilities:

·         Participated in Mapping out the business process (Manufacturing, UID generation, Distribution Center operations, transportation to Wholesaler, Retailer, EDI, ASN, E Pedigree) Work flows and data flows for product serialization.

·         Participated  in   evaluating  software package that uses global manufacturing and distribution center data to identify and track serialized pharmaceutical products from the manufacturer to the whole saler and retail customer in concordance with proposed regulations

·         Prepared User Acceptance Test scenarios to ensure that the applications meet the regulatory compliance  needs.

·         Participated in   GS1 Rx Secure Supply Chain discussions and HDMA Traceability Group calls, Third Party Solution Provider webinars .Summary updated to T&T Manager about the upcoming trends in the trade.

IT Environment: JD Edwards, EDI, DQSA, Quality Center, E Pedigree, Track and Trace and Rational toolsl

 

 

EIS   Inc                                                                                                                     Nov 12 to Aug 13

Role: Test  Lead

Project Summary: EIS is developing a Customer relation management application for pharma clients to measure their sales force effectiveness and track PDMA regulated activities. The application helps in tracking the sales calls and sample drops of the reps.

Key Activities & Responsibilities:

·         Developed Test strategy, SOPs, test requirements and acceptance criteria documents.

·         Resource planning, Use case preparation, training testers and offshore team management.

·         Conduct functional testing, integration testing, and data migration testing.

·         Coordinated User Acceptance Testing to ensure that the SFA and SAP applications meet the end customers day today needs.

·         Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation in compliance with CMMI

IT Environment: SAP ECC6.0, SFA, Quality Center and Share point.

Taro Pharmaceuticals USA                                                                                        Jun 12 to Oct 12

 Role: Project Lead 

Project Summary: Taro Pharmaceuticals is migrating from BPCS and Manhattan associates applications to Metis (In-house application development). The scope includes functionality validation and data migration from the legacy systems.

Key Activities & Responsibilities:

·         Reviewed and updated Test strategy, SOPs and acceptance criteria documents.

·         Reviewed and updated test cases in Quality center (HP QC) and created traceability matrix.

·         Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation.

·         Collaborated with members solution development team and other  stakeholders in ensuring timely delivery of deliverables 

·         Prepared Validation plans and validation summary report. Reviewed IQ, OQ and PQ documentation in compliance with CMMI

IT Environment: Metis, Rational tools, JIRA, PL/SQL, Cognos, IIS, Visual Studio, Manhattan Associates

Achievement: Successful go-live of project without any major surprises

 

Health Market Sciences                                                                                 Aug 11 to Apr 12

Role: Quality Lead

Health Market Sciences develop and implement MDM solutions for Life science clients to comply with state and federal regulations, reduce operational costs, and maximize market opportunities.

Key Activities & Responsibilities:

·         Monitoring and coordinating projects from initiation through delivery with test teams in US and Offshore location to keep projects on schedule and within budget.

·         Lead System testing, Integration Testing, End to End Testing and  User Acceptance Testing  activities to ensure that the SFA,SAP and MDM   applications meets the end customers day today needs.

·         Schedule/Time management in order to reach deliverables on time and within budget.

·         Develop, implement and enforce SOP and work instructions as per Good Documentation Practices in compliance with CMMI.

Environment: Master Data Management, Rational tools, Quality Center10.0, JIRA, Data Analytics and PL/SQL.

Achievement: Completed quality assurance management within budget and as per project timelines

 

Johnson & Johnson,                                                                                                            Aug 10 to Jun 11

Role: Quality Lead

This is the implementation of SAP at various business units of JNJ, addition of modules at the existing implementations and ongoing maintenance and support project where our team is responsible for testing all the development involved in rollout of new business and new projects in SCE and regular production support. J&J have implemented P2P (Procure to Pay) Application at the IT Global Finance department and rolled out to all the affiliates.

Key Activities & Responsibilities:

·         Test Planning for projects which includes Test Strategy and Test Requirements development

·         Test Artifacts development: Test Cases, Test Procedures and Test data extraction. Identify the data for Parameterization

·         Assigning Change requests to testing team. Addressing issues raised by offshore team during test execution

·         Execution of System Testing, Integration Testing and UAT.

·         Reviewing of Defects found and presenting it to the project team during the weekly review meetings.

Environment: SAP ECC6.0, Quality Center10.0, Aravo, Ariba, Business Intelligence and Share point.

 

Enterprise Info solutions                                                                            Feb 10 to July 10                                                                                                             

Role: Test Lead 

EIS Inc – implemented HCM, ESS/MSS and Financials ( AP, GL) Services  across PTC. This is a new implementation and involved to create BPP, Data Sets and manual & automated Testing process.

Key Activities & Responsibilities:

·         Written  Test Plan and reviewed test scenarios for the SAP suite

·         Reviewed the  design documentation to ensure functionality has been covered  , tested and  delivered

·         Provides input into testing activities to occur in each test phase and environment. Manages and monitors test acceptance criteria.

·         Executed the scenarios as per the scenarios designed by the functional team.

·         Implemented and upgraded to ECC 6

·         Supervise the project team and user testing, tracking bugs and ensure all the defects have been fixed before go-live.

·         Developed  QTP re-usable scripts for the purposes of Regression and Upgrade testing

·         Performed Parallel, Security and module testing as per the Business Process Procedure ( BPP)  by Functional Specification

Environment: SAP ECC6, SAP R/3, Oracle 9i.0, SQL Query Analyzer 5.0

Bristol-Myers Squibb                                                                                                          June 09 to Jan 10                                                                                                                                   

Role: Software Quality Consultant

BMS implemented Navigator, a mobile intelligence application for measuring the sales force effectiveness and sample disbursements to physicians.

Key Activities & Responsibilities: 

·         Worked as Quality & Compliance Consultant for the implementation of Navigator, the web based application for measuring the sales force effectiveness. Application was tested in FDA regulated environment for its quality and compliance to 21 CFR Part11 using Standard Operating procedures.

·         Developed test cases that map to user requirements and maintained the summary in a traceability matrix.

·         Executed the Test scripts Using Quality Center and entered the Defects into HPQC for tracking purposes.

·         Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation

·         Conducted UAT with the end users enabling that the application meets their field requirements.

·         Attended the end user review meetings and collected their feedback regarding the Navigator user friendliness.

·         Worked with other members of the SFA team, IT, and QA to ensure that a quality product is deployed.

·         Completed all required pre & post-testing documentation in compliance with 21 CFR Part 11 guidelines, in accordance with the company’s computer systems validation policies and within project deadlines.

Achievement: Completed quality assurance management within budget and as per project timelines

EIS   Inc                                                                                                               Sep 08 to May 09                                                                                    

Role: SAP Integration Test Lead -

 EIS participated in the implementation of SAP SCM-APO Upgrade Project from 4.1 to 5.1. This implementation involved to create BPP, Data Sets and manual & automated Testing process.

Key Activities & Responsibilities:

·         Written Test Plan and designed test scenarios for the SAP suite as per the scenarios designed by the functional team.

·         Reviewed the  design documentation to ensure functionality has been covered  , tested and  delivered

·         Provides input into testing activities to occur in each test phase and environment. Manages and monitors test acceptance criteria.

·         Managed the test team during testing, tracking bugs and ensure all the defects have been fixed before go-live.

·         Responsible for   QTP re-usable scripts for the purposes of Regression and Upgrade testing

·         Performed Parallel, Security and module testing as per the Business Process Procedure ( BPP)  by Functional Specification

·         Issues were   documented, assigned, communicated , including tracking defects in Mercury Quality Center 9.1

·         Conducted team meetings and review the issues in the meetings

·         Performed  Functional, Regression, Integration testing for the  modules

Environment: SAP SCM APO, SAP R/3, Oracle 9i.0, SQL Query Analyzer 5.0,  HP-Quality Center 9.1, U-Perform, Mainframe .

Cegedim Dendrite Inc.                                                                           Jul 2000 to Jun 2008                                                                                                                                Role: Quality Lead

Cegedim Develops and implements   CRM, SFA, BI and Analytic solutions with FDA compliance to all the Life sciences clients .These solutions help in Targeting the customers and measuring performance of the activities.

Worked on Baseline product development testing for pharma companies Sales Force Automation and Mobile Intelligence implementation Projects:  The project involved functionality testing, integration testing and data migration testing to ensure that there were no data leakages.

Key Activities & Responsibilities:

·         Lead and Participated in test planning, test case creation, analysis and implementation for Sanity testing, Installation testing, Front-End testing, Back-End testing, Full-Cycle testing, UAT and Data-Migration testing.

·         Participated in requirement gathering, GAP analysis and risk analysis for testing the application.

·         Prepared Validation Plans and Validation Summary reports. Reviewed IQ, OQ and PQ documentation

·         Ensured testing procedures are in compliance with established processes (SOP and Work Instructions).

·         Responsible for test environment, test resources, test documentation and defect tracking.

·         Worked closely with the developers and project managers in the identification and resolution of defects and defect  metric reports. Prepared reports on project progress and problems. Provided direction and supervision to junior team.

·         Developed Lessons Learned, that defined the aspects of the project that were a success and highlighted, the aspects that needed improvement, by providing improvement options.

·         Involved in Random Audits, Vendor Audits, Process and procedural Remediation Third party Audits and Reconciliation.

 

Baan Institute     India                                                                                                   8/1998 - 10/1999                                                                                                                                                                                        

Logistics Consultant,

Baan Systems Involved in Development and consulting on implementation projects, training end users and implementers, model building for ERP implementations     

•             Consultation on projects implementation and supporting them at Implementation sites, training the implementers and Boundary Spanners in advanced Business process areas, assisting the global support group in handling their customer complaints.

•             Involved in testing of the application.                   

Forbes Forbes Campbell Co Ltd.  

A Tata Group company involved in shipping line agency business, International freight forwarding (3PL) and vendor management for major buying houses worldwide.

Responsibilities include

 

·         Managed an office with responsibilities for business forecasting, client and business development, customer service, Supply chain improvement, operational complia