Skills And Experience Required
LabVantage LIMS, JIRA, and EDMS Experience:
- Proficiency in working with LabVantage LIMS, JIRA, and EDMS is highly preferred.
Cross-Functional Stakeholder Collaboration
- Ability to collaborate with cross-functional stakeholders on large and complex system validation projects.
Regulatory Compliance Knowledge
- Familiarity with regulatory requirements for non-product and product software such as 21 CFR Part 11, part 820, Annex 11, IEC 62304, etc.
- Must be able to effectively respond to CSV-related regulatory and compliance queries.
Quality Assurance Methodologies
- Extensive knowledge of QA methodologies, including test planning, system dependencies, and software SDLC phases.
Task Execution And Teamwork
- Capable of executing tasks efficiently both independently and within a team.
- Strong communication skills to effectively collaborate and communicate with team members and stakeholders.
Employment Type: Contractor