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Computer Systems Validation Specialist

Morristown, NJ, US
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COMPANY: QPHARMA, INC.

JOB TYPE: Permanent, FullTime

We are currently looking for a Computer System Validation Specialist for our Morristown, NJ or Raritan, NJ location. Responsibilities include, but are not limited to: Perform risk assessments for change control activities System integration and validation testing for new/enhanced web applications Testing of data integrations with specific CRM Prepare deliverables associated with validation testing (functionality, system integration, data migration, regression and interface file testing) including: Risk Assessment, User/Functional Requirement Specification, Traceability Matrix, Project Validation Plan, Installation Qualification/Operational Qualification/Performance Qualification, deviation resolution and Validation Final Report Review executed system testing and validation test scripts Requirements: Bachelor’s degree Minimum of 5 years System Development Life Cycle experience, including system integration and validation testing Software quality assurance Experience in manual testing Experience in the Life Sciences industry Knowledge of FDA regulatory requirements, including 21 CFR Parts 11 and 820 Excellent communication (oral and written) and organizational skills Ability to work independently and in a team setting Strongly desired: Knowledge of 21 CFR Part 203 CRM Systems Ordering and Inventory Management SQL Queries Agile Methodology API testing tools Test Automation Tools
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