Employment Type : Full-Time
Job Opening for Contractor, Quality Systems - Software QA Contractor, Quality Systems - Software QA is responsible for supporting QA review of software development lifecycle documentation with a specific focus on validation/implementation of new software systems. Primary Responsibilities Include: Qualification:
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• Review/Approve Test Scripts
• Review Validation Summary Reports, Installation Qualification, Operational
Qualification, Perfformance Qulaification, and Trace Matrices, escalate issue to management
• Support the development of training content
• 5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
• Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
• Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
• Ability to work independently to meet objectives and timelines
• Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
• Prior experience with electronic test systems preferred (e.g. Valgenesis, Kneat)