Description

You will manage the validation of large, complex laboratory information management systems and ensure compliance with global regulatory standards.

Responsibilities

• Support the validation of complex systems using LabVantage LIMS, JIRA, and EDMs.
• Collaborate with cross-functional stakeholders to execute accurate and efficient system validation.
• Respond to CSV-related regulatory and compliance inquiries regarding product and non-product software.
• Apply QA methodologies, test planning, and software SDLC phase expertise to drive validation success.
• Manage system dependencies and task execution independently or within a team.

Required Skills

• Hands-on experience with LabVantage LIMS.
• Proficiency in JIRA and EDMs.
• Deep understanding of regulatory requirements including 21 CFR Part 11, Part 820, Annex 11, and IEC 62304.
• Practical knowledge of QA methodologies and test planning.
• Experience navigating software SDLC phases and system dependencies.
• Strong written and verbal communication skills for stakeholder management.

Preferred Skills

• 1 year of tenure in LIMS validation or CSV specialist roles.

Key Skills

Education

Not specified