Test Lead

Years of Experience : 8 years

Role : Test lead - Onshore

Preferred Role & Qualifications are listed below

• Ability to Understand the Clinical Data Repository-Statistical Computing Engine(CDR-SCE) System through Knowledge transfer and play the role as Test lead
• Good Computer system validation Testing experience. Ability to Assess the Client QMS SOPs and understand the project landscape and come up with realistic test & validation estimates.
• Good with Functional Testing , ETL testing and Data Migration Testing in GxP space.
• Knowledge on Cloud , AWS, Clinical Systems ( CDR , SCE etc)
• Excellent communication skills
• Create Or Review the test scripts from Offshore
• Lead the Testing & validation team.
• Participate & Coordinate in the Test script review session with clients – IT / Business / Quality and get their feedback and fix them during EST hours

• Educate business SMEs through shadow dry run activities ​
• Execute test scripts during Onshore hours in order to meet the release timelines​
• Manage and add efficiency for defect management during onshore hours​
• Facilitate and manage reviews of test execution with different stakeholders across Quality, Business and IT
• Address feedback from business on the Test scripts
• UAT test design & Support during UAT execution .
• Knowledge of working in HP ALM is preferred
• Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
• Proven experience developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC or Agile phases
• Experience in working with Pharma/Biotech implementation of R&D systems
• Preferred Time zone of working – US Central Time Zone (Evanston , IL)
• May need to coordinate with various technical Team at offshore for Validation related work
• Knowledge to conduct Installation / Infrastructure Qualification exercises
• Knowledge of CSV and experience in working /leading CSV testing projects – Must
• Familiar with cloud/ETL concepts - Preferred

Additional Skills:

· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint)

· Good Verbal and non-verbal communication skills

Job Type: Contract

Salary: $35.45 - $75.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Quality assurance: 10 years (Required)
• system validation Testing: 3 years (Required)
• Test automation: 5 years (Required)

Willingness to travel:

• 25% (Required)

Work Location: Multiple Locations