CSV Lead
Hptech Inc.
Raritan, NJ, United States
11 days ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Job source
Tech stack
Automation of Tests
Laboratory Information Management Systems
Systems Development Life Cycle
System Testing
GXP
Requirements
- Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
- Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
- Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
- Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
- Ability to Review Automated Test script Strong verbal and written communication skills.
- Ability to work as a team player, lead a team or accomplish tasks without supervision.
- Ability to work with remote teams and support several changes/projects simultaneously.
- Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
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