Responsible for managing a team, planning activities, creating test plan, requirements Traceability Matrix and standard templates (Daily status, defect status etc.)
Responsible for assigning tasks and managing the onsite and offshore teams.
Write and review quality test cases based on product functional requirements and in accordance with applicable standard operating procedures
Execute test cases according to instructions and in compliance to Good Documentation Practices
Report and assist in resolution of issues encountered during testing
Analyze/triage issues encountered during testing, both of own testing and others’, and escalate appropriately when required.
Supervise work of other testers.
Identify the tools for test reporting, test management, test automation, etc. and educate the team on how to use those tools.
Plan knowledge transfer sessions if required to the team members for the tools that they would use.
Other duties as assigned.
Work Experience:
Minimum of 5 years’ experience in software testing under an SDLC designed for pharmaceutical or similar regulatory compliance.
Prior experience supervising teams of personnel helpful.
Prior work experience in FDA-regulated environment helpful.
Technical Knowledge:
Proficient working in Microsoft Office applications
Knowledge of domain and applications being tested
In-depth understanding of FDA GMP/QSR regulations and associated requirements for electronic records and Good Documentation Practices
In-depth understanding of validation expectations for FDA regulated companies.
Education Requirements:
Bachelor’s degree in a scientific, regulatory, or technical discipline, or Associates degree and minimum of 5 years previous work experience in regulated industry
Equivalent prior work experience may substitute for degree requirements at discretion of Manager.
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