SQA Validation Engineer

Responsibilities

• Software Quality Assurance with Review and Approval Experience for SDLC Deliverables
• Experience should have SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release)
• Strong Validation Resource with 10+ yrs Experience / Responsibilities
• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures
• Work autonomously with related IT contacts and the business process SMEs for this purpose
• Support as SQA in the Review and Approval and implementation of regulated IT applications
• Ensure continuous improvement and gives input related to the validation strategy for IT changes
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met

Qualifications

• Experience with Multiple Tools/Applications such as but not limited to JIRA, Confluence, HP-ALM, Tosca, Confluence, Veera, Qtest, M-Files, Microsoft Teams and other tools such as the following are a plus: Data Lake, AWS, Databricks, Github, or other continuous integration tools
• Good experience in Review of CAPA’s, Change Control and Defects as it applies to Software Validation while concurrently having good soft skills such as a good and effective communicator and vocal during meeting and projects
• Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification)
• Previous experience validating systems
• Proficient in understanding of GxP regulations and validation principles
• Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner
• Highly self-motivated, self-directed
• Understanding of risk management principles, regulatory requirements and, industry best practices
• Knows the difference between Waterfall and Agile software development methodologies
• Previous experience with automated testing and implementation
• Familiarity with a range of applications/tools including JIRA, Confluence, HP-ALM, Tosca, Confluence, Veera ,Qtest, M-Files, or other continuous integration tools