Description

You will manage validation and compliance for complex software systems within a regulated environment.

Responsibilities

• Execute test planning and manage system dependencies throughout the software SDLC.
• Collaborate with cross-functional stakeholders on large-scale system validation projects.
• Respond to CSV-related regulatory and compliance queries.
• Perform tasks independently and as part of a technical team to meet project goals.

Required Skills

• 5 years of experience in quality assurance or system validation.
• Proficiency with LabVantage LIMS.
• Experience using JIRA for task and defect management.
• Experience with EDMS.
• Knowledge of 21 CFR Part 11 and Part 820.
• Familiarity with Annex 11 and IEC 62304 regulatory requirements.
• Understanding of QA methodologies and software SDLC phases.
• Strong technical communication skills for stakeholder collaboration.

Key Skills

Education

Not specified