DDi, A Global Smart Technology Products & Innovative Solutions Provider with Enterprise-class Infrastructure and Services. We are certified ISO 9001:2015, ISO/IEC 12207 and ISO ICE 20000.
QA Analyst
1) Review and Analyze Functional, business, product requirements, convert them in to test scenarios and test cases by performing boundary value analysis.
2) Create functional and end to end test scenarios and cases.
3) Create test data as required perform smoke, functional and regression testing by executing test cases.
4) Log defects for failed test cases, track defect status during the testing cycle.
5) Interact with developers and business analyst during all the phases of project development and testing.
6) Conduct defect review meetings with in the testing team and other project stakeholders.
7) Provide testing status and issues to test lead on daily basis during the testing cycle.
8) Create test results report and test summary report, Requirement traceability matrix.
9) Perform any other testing activities as needed like validation testing, Security testing, automation and performance testing.
10) Knowledge of IQ, OQ, PQ, 21 CFR part 11 regulations, GMP5 will be an added advantage.
Technical Qualification: Manual functional and regression testing, test plans, test cases, test automation and defect tracking.
Any other specifications: knowledge on clinical trial products, FDA, EU compliance, GAMP4 and GAMP5 and 21 CFR part 11
DDi | A MakroGroup Company | www.DDIsmart.com
A Global Smart Technology Products & Innovative Solutions Provider with Enterprise-class Infrastructure and Services. We are certified ISO 9001:2015, ISO/IEC 12207 and ISO ICE 20000.
DDi Awarded as:
• The 10 Most Trusted Risk and Compliance Solution Providers - Insights Success
• TOP 25 Governance, Risk & Compliance (GRC) - CIO
• Innovation & Excellence Award for Excellence - Corporate LiveWire
• 50 Fastest Growing Global Private companies
• Top 10 Clinical Data Management Solution Provider - Pharma Tech Outlook
• Best Technological Development in Clinical Trials - SCRIP
• CR 20 Most Promising Medical Technology Companies
DDi Products:
• mEDC - Web based electronic data capture system.
• mCODER - Web based auto coding system .
• mPORTAL - Drug development activities Integrate, Collaborate & Innovate
• mIRT - Global Clinical Supplies Management Solutions
• REWOD - Prospective data collection
• VISU - Regulatory Information & Submission Management software
• LABELai - Next Generation Labeling Automation Platform
• TULA - AI driven Performance, Risk Management & Quality Compliance
• REGai - Regulatory Automation
• Vistaar - Automating Clinical & Regulatory Compliance
• YANA - Robotic Process Automation, AI, ML, and Digitization
• safeXchange - Automation Solution for Data & Medical Writing
About Makro Group | www.MakroGrp.com
Makro Group of Organizations established in 1996, Makro provides a complete range of solutions for every stage of business and information lifecycle.
• MakroCare, DDi, MakroTech and MakroScientific are MakroGroup Companies
• Makro is Certified ISO 9001, ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155
• MakroCare Awarded by Global Health & Pharma, UK Enterprises, Insights Success, Acquisition International, Clinical Informatics, US Institute for Excellence in Commerce, US Commerce Association, Scrip Awards & MerchantCircle
• MakroTech is Awarded 3-time FAST 500 (Deloitte), 3-time INC 5000 company & TOP 100 diversity business in NJ
• MakroFoundation is a Suicide Prevention Helpdesk, part of Makro CSR Initiative, has counseled over 3000 people