Sathish Gajendran Email and Phone Number
15+ years of experience in IT which includes proficiency in Computer System Validation (CSV) and Computer Software Assurance (CSA), Creation and Review of Validation documents/deliverable s, Mobile Testing, Automation Testing, Functional Testing, Waterfall/Agile methodology, Regulatory Compliance, data migration testing, GAMP5, 21 CFR Part11 and GxP.
Astrazeneca
View- Website:
- astrazeneca.com
- Employees:
- 59317
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Senior It Quality ManagerAstrazeneca Sep 2024 - PresentTamil Nadu, India -
Senior ConsultantInfosys Ltd. Sep 2021 - Sep 2024Tamil Nadu, IndiaAs a PQM handling ERP IT, Commercial and Digital projects, by using Optimise Waterfalland Agile methodologies.• Ensure an effective compliance process is established and implemented during the process of software application development and maintenance.• Ensuring the project specific process, procedures and work instructions are following, controlled and communicated effectively to the team.• Ensure industry Standard and Regulatory requirements are fulfilled.• Defines the approach/strategy for End-to-End Validation projects (GxP/Non-GxP) for the Applications.Reviewing and monitoring adherence to the project specific process, procedures and work instructions.• Act as SPOC to manage Methodology issue, Deviations, Escalation point of contact during the rollouts.• Co-ordinate with key stakeholders (QA/Project Leads/PMs/SteeCo) on various project aspects like, communication, alignment and defining the milestone. Also, Facilitates the Phase review meetings with key stakeholders.• Authoring (Validation Plan, Quality Plan and Validation Report etc.) and reviewing all project deliverables and life cycle documents.• Compliance review of all the validation documents (URS, FS, DD, Risk Assessment, IQ, OQ, PQ scripts, TSR, Traceability Matrix etc.) for all SDLC/Project phases as defined in QMS/ WI/SOP’s.• Ensuring the waterfall and agile approach has been followed in the projects as defined in the SOPs for different services (ERP IT and Commercial IT).• Ensuring the project team follows quality deliverables and timely closure of CAPA.• Ensuring the each project should have complete the CAIRO assessments (Security Risk Assessment, Third Party Assessment, Data Privacy Assessment) -
Technical LeadWipro Limited Nov 2018 - Sep 2021Chennai, Tamil NaduTechnical Lead - Quality Assurance -
Test Lead & Val AnalystCognizant Technology Solutions Apr 2014 - Nov 2018ChennaiProject title: HCPro 5.0, 4.9, 4.8, 4.7, 4.6, 4.5 Project Size : 13 Members.Project Description:HUMIRAlink, also known as HLink is a unique, in-Office technology platform that automates the capture of prescription information to accelerate approval, ensures greater accuracy, and connects patients to important on-boarding services. The system will send this information to Pharmacy Solutions or other partner for Benefits Verification and the patient’s Insurance Company for Prior Authorization processing.Role and Responsibilities:• Requirement Analysis using Functional Flow Documents.• Involved in creation of Test Plan • Clarification tracker Maintenance in Client Share Path.• Preparation of Test Scenarios.• Preparation of Validation test cases. • Review of Validation test cases drafted by the other offshore team members.• Validation Dry Run and Validation test execution.• Defect Management in Client Share Path.• Issue Retesting• Performed Ad-hoc testing.• Participated in the status review meetings.• Involved in Defect Triage with the Development team.• Preparation of Requirement Tractability matrix.• Sending Status emails to Client and keeping track of the activities performed by other team members.• Conducted KT sessions to new team members.• Involved in Client Demo and Interacted with the client to understand their requirements.• Using SOAP to check benefit verification from third partyAutomation:• Feasibility studies for different application• Designing and Debugging the scripts both sanity and regression• Used keyword driven approach in UFT 12.02• Executed the script with QC integration -
Software Qa AnalystCognizant Technology Solutions Feb 2014 - Mar 2014Chennai Area, IndiaThe Service Management Solution is consider a SaaS solution provided by the ServiceNow vender. -
Val AnalystCognizant Technology Solutions May 2013 - Jan 2014ChennaiValidation Testing is done on the Secured page in the Web browsers like Internet explorer, Chrome, Firefox and Mac OSX Safari. Apart from Validation & functional testing the web solution had to be tested for browser compatibility with browsers like IE8.x, 9.x, Mac OSX Safari, iPad iOS safari andChrome. The native Gmail & Yahoo was tested for the devices iPhone and IPad.Role and Responsibilities:Manual:• Requirement Analysis using Functional Flow Documents.• Preparation of Test Scenarios.• Preparation of Validation test cases. • Review of Validation test cases drafted by the other offshore team members.• Data Base testing• Validation Dry Run and Validation test execution in paper based.• Defect Management in Client Share Path.• Performed Ad-hoc testing.Conducted knowledge transfer sessions for the new joiners in the project team.Ensured on time delivery of test. Track operation clarity effort metrics for the team. -
TesterCognizant Technology Solutions Oct 2012 - Apr 2013ChennaiProject Title : E-detailingProject Size : 10 MembersProject Description:E-Detailing is often used as blanket term for various online physician marketing, promotional and communication activities. E -Detailing helps both sales representatives and physicians with a great way of getting the information they want at a time that suits them. Simply stated, e-Detailing is detailing done electronically, most often online via Internet, sometimes with personal computing devices (e.g., PDAs) or Via Internet-enabled tele/Video Conferencing.Role and Responsibilities• Requirement Analysis for functionality and Contents • Performed device compatibility testing across various IOS devices (both IOS 7 & 8)• Reporting the Defects in JIRA Bug track tool• Regression testing• Preparing Knowledge Based documents• Preparing the defect metrics report for regular (weekly, monthly,) presentation of data to the management -
Team Lead, Trainer & AuditorCognizant Apr 2009 - Sep 2012Chennai Area, IndiaAssurant HealthDomain : Health Care Tools : Cruise v12.1 & Mainframe SessionProcess Responsibilities:• Involving in routing the faxes to department named UW Individual medical new business applications using File Net Index Main tool, Supplemental coverage like Accident, Dental, Term Life and Critical Illness application.• Identifying the submitted faxes like Medical records or Unsolicited Medical Records and route it to the departments concerned.Role Responsibilities:• Involved in analyzing the defects and preparing defect tracker. Defect tracker includes Pareto analysis in error wise, associate wise, monthly wise, category wise and priority wise• Consolidate the process related data on a large scale in spreadsheets for data interpretation• Regular (weekly, monthly, bi annual, annual) presentation of data to the management and quality and operational staffs for forecast of development at all levels
Sathish Gajendran Education Details
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Ide Madras UniversitySystem Management -
Madras UniversityInformation System Management
Frequently Asked Questions about Sathish Gajendran
What company does Sathish Gajendran work for?
Sathish Gajendran works for Astrazeneca
What is Sathish Gajendran's role at the current company?
Sathish Gajendran's current role is IT QM.
What schools did Sathish Gajendran attend?
Sathish Gajendran attended Ide Madras University, Madras University.
Who are Sathish Gajendran's colleagues?
Sathish Gajendran's colleagues are Samiyah Ali Khan, Sara Dekalb, Ingrid Tothova, Tu Tran Vinh, Erica Mildred Forero Ariza, Dr Lenu P., Gabriella Catanzariti.
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Sathish Gajendran
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