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Responsibilities:

Software Quality Assurance with Review and Approval Experience for SDLC Deliverables.

Experience should have earlier in career in SDLC/Software Validation with writing and execution of SDLC deliverables (e.g. MVP testing).

Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix, and System Release).

Several years of SQA experience with Review and Approval of SDLC deliverables (e.g. MVP, Risk Assessment (FMEA), Requirements, IQ, OQ, PQ, Trace Matrix and writing of System Certification).

Support as SQA in the Review and Approval and implementation of regulated IT applications.

Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

Requirements :

Strong Validation Resource with 7+ yrs Experience.

Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.

Previous experience with automated testing and implementation.

Proficient in understanding of GxP regulations and validation principles.

Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation.

Familiarity with a range of applications/tools including JIRA, Confluence, Client-ALM, Tosca, Confluence, Veera ,Quest, M-Files, or other continuous integration tools.

Knows the difference between Waterfall and Agile software development methodologies.

Authorized to work in the United States for any employer or proper documentation if associated with a third-party agency.

Must pass background and reference checks.

Read the full job description and apply online on the recuiter's web-site

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