What are the responsibilities and job description for the Pharma software Quality Engineer position at KoreRPO?
Job Responsibilities
Software Quality Assurance (SQA) :
Conduct review and approval of SDLC deliverables, ensuring compliance with regulatory and company standards.
Perform software validation tasks, including writing and executing SDLC deliverables such as MVP testing, risk assessments (e.g., FMEA), requirements documentation, IQ, OQ, PQ, traceability matrices, and system release documentation.
Develop and write system certification documentation.
Regulated IT Application Support :
Provide SQA support for the review, approval, and implementation of regulated IT applications.
Collaborate with development teams to build compliance capabilities, ensuring deliverables meet quality standards and business requirements.
Quality and Compliance Assurance :
Ensure IT validation packages are inspection-ready and comply with company policies and procedures.
Conduct reviews of CAPAs, change controls, and defects as they relate to software validation.
Support the implementation of automated testing tools and practices.
Responsibilities
Requirements
Experience and Expertise :
Minimum of 8 years of experience in validation, particularly in the review, approval, and execution of SDLC deliverables.
Proficient in GxP regulations and validation principles.
Strong understanding of both Waterfall and Agile development methodologies.
Technical Skills :
Familiarity with tools and applications such as JIRA, Confluence, Tosca, Client-ALM, Qtest, Veeva, M-Files, or other continuous integration tools.
Additional Qualifications :
Authorized to work in the United States or possess valid documentation if working through a third-party agency.
Ability to pass background and reference checks.
This role requires a strong background in software validation, quality assurance, and regulatory compliance to ensure successful implementation and maintenance of IT applications.
