Sr. Software Quality Assurance - SME

Required:

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, Risk 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)

Also, should have good experience in Review of CAPA’s, Change Control and Defects as it applies to Software Validation while concurrently having good soft skills such as a good and effective communicator and vocal during meeting and projects.

Experience with Multiple Tools/applications such as but not limited to JIRA, Confluence, HPALM, Tosca, Confluence, Veera, Qtest, MFiles, Microsoft Teams and other tools such as the following are a plus:
Data Lake, AWS, Databricks, Github, or

other continuous integration tools

• Strong Validation Resource with 10+ yrs Experience Responsibilities
• Ensure IT validation packages are inspection ready and in compliance with applicable company policies and procedures.
• Work autonomously with related IT contacts and the business process SMEs for this purpose.
• Support as SQA in the Review and Approval and implementation of regulated IT applications.
• Ensure continuous improvement and gives input related to the validation strategy for IT changes.
• Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are met.

• Must have previous experience validating systems
• Proficient in understanding of GxP regulations and validation principles
• Strong analytical skills with the ability to organize work in a logical, thorough and succinct manner.
• Highly self-motivated, self-directed
• Understanding of risk management principles, regulatory requirements and, industry best practices.
• Knows the difference between Waterfall and Agile software development methodologies
• Previous experience with automated testing and implementation
• Familiarity with a range of applications/tools including JIRA, Confluence, HP-ALM, Tosca, Confluence, Veera ,Qtest, M Files, or other continuous integration tools
• Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams
• Role must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.