Validation Lead – Pharma/BioTech focused

Requirements:

Must Haves

1. 8+ Years Testing Experience
2. Ability to Understand the Clinical Data Repository-Statistical Computing Engine(CDR-SCE) System through Knowledge transfer and play the role as Operational Team Test lead
3. 5+ Years of CSV Experience within Pharma/BioTech Industries
4. HP ALM Experience
5. Strong knowledge of industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.

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 Operational Team Test lead
• Create Or Review the test scripts from Offshore
• Lead the Testing & validation of Ops team.
• Participate & Coordinate in the Test script review session with clients – DCM / Business / ITQM and get their feedback and fix them during EST hours
• Parallel execution of CDR and SI testing during Dry run and System Testing
• 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 ITQM, Client Business and ITQM
• 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 Eastern Time Zone
• May need to coordinate with Ops 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