SQA SME

SQA SME

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a SQA SME. Position Type:

• Contract
• On-Site

Required:

• 10+ years' of strong validation experience.
• Software Quality Assurance with Review and Approval experience for SDLC Deliverables.
• Experience 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).
• 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).
• Good experience in Review of CAPA's, Change Control and Defects as it applies to Software Validation.
• Good and effective communicator and vocal during meeting and projects.
• Experience with multiple tools/applications such as but not limited to JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, Microsoft Teams and other tools such as the following are a plus:
  Data Lake, AWS, Databricks, Github, or other continuous integration tools.
• 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.
• 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.

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.

Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Jeevesh at  to learn more.