Hi Associates/ Partners/ Friends, Hope you are doing great!!!
This is Kumar from Javaji System Solutions Inc., We have an opening with my client who is looking for Test \ QA Lead (3 Requirements).… *1. Position: Validation Test Lead Duration: 6 Months Location: Durham, NC...* * Job Description:* - Extensive experience in validation testing (test scenario preparation and test execution) in Clinical Trials domain. - Experience using Quality Center for test planning, execution and defect management. - Experience in handling a team of 2-4 members and exposure to Test management. Note: Customer interview will happen before final selection. *Similar to the profile below :Profile as below :* • 10+ years of experience in computer system validation performing validation, testing (QA), business analysis, and technical writing in the Pharmaceutical and Medical Device Industry • Experienced performing System Testing and User Acceptance testing (UAT) for various software applications that are used in pharmaceutical business processes within GMP, GLP and GCP environment • Experienced validating and testing computer systems that comply with FDA regulations 21 CFR Part 11, Part 210, 211and QSR 820 • Experienced writing and reviewing documentation for all phases of computer system validation (CSV) life cycle • Experienced generating both procedural (SOPs, work instructions, user manuals, admin guide, etc.) and quality system (user requirements, functional requirements, validation plans, test plans, etc.) documentation to ensure they comply with FDA regulations and company policies • Experienced generating documentation for various systems such as Oracle Clinical (Clinical Data Management System integrated with Remote Data Capture), Cognos Reports, Siebel Call Center (CRM system), TrackWise, Plant Edition, ARTS Custom Reports, Argus Safety, Rave, eRT eData Management system (eDM), eData Entry System (eDE), Clinical Trial Management System (CTMS), GE Kaye LabWatch Monitoring System, Building Management System (BMS), LIMS and Adverse Event Reporting Systems (AERS) • Experienced generating the validation deliverables at each phase of SDLC including, but not limited to, Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specification (URS), Functional Requirements Specification (FRS), Software Design Specification (SDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM) and Validation Summary Report (VSR) • Experienced working with Plateau’s Learning Management System (LMS) for training purposes • Experienced performing 21 CFR Part 11 compliance and risk assessments for various software applications and systems that are used in pharmaceutical companies • Experienced supporting change control and Corrective and Preventive action (CAPA) • Experienced using SQL loader to load large amount of data in clinical systems. • Experienced using Database Query tools such as TOAD • Thorough knowledge of all FDA regulations including Prescription Drug Marketing Act (PDMA) • Experienced working with various methodologies such as Fish Bone methodology and Navigo methodology • Project lead and validation lead experience • Experienced implementing Sarbanes-Oxley Act (SOX) during the project life cycle • Experienced working with document management systems such as EPIC STAR and Val Genesis (Validation Management System) • Worked with Mercury Interactive tools Win Runner, Load Runner and Test Director • Generated Gap Analysis for various systems and documents *2. Position: Sr. Test Lead (QC, Functional Testing, SQL Testing) Duration: 6 Months Location: Dallas / Plano, TX...* * Job Description:* - Sr. Test Lead is responsible for evaluating Business Requirements, Functional Specs, TDD and designing, developing, creating, and executing test plans, Business process Components . - Strong skills in understanding the application architecture and have assisted/participated in setting up the test environment - Should have experience working in huge/complex systems integrating with various other systems upstream and downstream • Experience in Retail Industry is also highly desired • Experience as Onsite/Off shore Coordinator and provide technical direction and expertise to testing groups in Offshore team • Very well verse with Business Process Testing, creating business components • Closely worked with Developers, Users • Strong in SQL, Database testing knowledge • Technically sound with client server applications • Experience utilizing QC/BPT, Performance Center • Experience in creating test metrics • Support the QA Lead with test results and status as communication to the onsite/offshore team • Self starter, Individual and Team Player with Strong verbal and written communication skills to effectively interact with technical and business teams *3.Position: Webservcies Performance testing using JMETER Duration: 6 Months Location: Portland, OR...* *Skill: Webservcies Performance testing using JMETER Job Description:* At least 4 years of experience in Web Services testing with JMETER tool (this is mandatory) Experience in Performance testing Excellent communication skills as this person will be talking to the tech architects and director level stakeholders directly. Exp with LOAD RUNNER Exposure with DB testing will be plus 5+ yrs of testing exp on environments like WebLogic, J2EE, HTML, XML, SQL programming, PL / SQL Working experience in Quality Center *Please submit 100% matching resumes to **ku...@javaji.com*<ku...@javaji.com> Thanks & Regards, Kumar Javaji System Solutions Inc., 703 880 4142 703 880 7232 (Fax) ku...@javaji.com Google IM: kumar4mjss www.javaji.com
