Our Quality Assurance (QA) team at Trialspark is looking for an experienced Quality Software Engineer to participate in the ongoing implementation of our Software Quality Management Systems (QMS) & Software Development Life Cycle (SDLC) processes in conformance with US FDA Quality System Regulations & ISO 13485 Design Controls. This role is embedded with the engineering & product teams to help continuously qualify & validate our software tools.
- Independently review Good Practices (GxP) Document Deliverables as a Subject Matter Expert (SME), approving/authorizing key documents such as User Requirements Specifications, Validation Plan, Risk Assessment, Test Protocols/Reports, Validation Summary Report, & releasing systems into production;
- Ensure GxP document deliverables are consistent & in compliance with corporate policies & procedures following Food & Drug Administration (FDA) regulations, & facilitate a risk-based lifecycle approach form business process description through system retirement;
- Guide in System Validation of Software as a service (Saas) tools for study-specific intended use, Data Integrity, Code of Federal Regulations (CFR) 21 Part 11 Compliance, Audit Preparation & Support, Data Migration, & Release & Change Management Process;
- Work in close collaboration with Engineering & Product Teams;
- Investigate validation discrepancies, drive deviation management, & create best-practices for system validation including Computer System Validation (CSV) training & workshops;
- Serve as Software SME in support of audits & regulatory inspections;
- You have a degree in Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field
- You have at least 3 years of relevant experience in software validation & change management in the pharmaceutical industry.
- You have a deep understanding of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11, computer systems validation requirements & good documentation practices.
- You have demonstrated strong project management skills & enjoy working collaboratively with software development teams.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.