Role Compliance- SQA
No of Positions 1
Experience 5-10 Years
Technical Competencies- SDLC Process, Compliance Knowledge, Agile, Scrum, Technical Documentation, Project Risk Assessment
- Responsible for facilitating the project with the organization defined QMS
- Assisting the project manager with PGP and setting up the metrics for the project
- Review of the plan documents and contract documents of the project
- Conducting risk reviews for the project
- Conducting the metrics analysis of the project
- Conducting the internal quality audits
- Preparing project teams for the external\client audits
- Experience in authoring and reviewing deliverables like OQ/PQ documentation, Traceability Matrix, and reviewing User/Functional requirements specification for clinical products.
- Experience in authoring, reviewing and executing Operational Qualification (OQ) scripts based on Functional specification.
- Experience in authoring, reviewing and executing Performance Qualification (PQ) scripts on User Requirements specification.
- Excellent Knowledge and experience in Good Documentation Practices
- Work experience on ISO 9001:2008, CMMI Dev V1.3, SOC Controls and ASPICE V3.0.
- Good knowledge on Agile-Scrum framework such as Sprint Planning, Sprint Release, Sprint Review & Sprint Retrospective meetings.
- Good knowledge of Software Development Life Cycles and its application to projects.
- Facilitating the Management review meetings and SQA reviews.
- Conducting internal audits.
- Audits reporting, conducting Root cause analysis and audit follow-up, process improvement facilitation.
- Experience in process consulting, in implementations In line with ISO 9001:2008, SOC framework, CMMI DEV 1.3 and ASPICE V3.0.
- Implemented CMMI Dev – 1.3 at Ram Informatics private Limited.
- Participated in External Audit conducted by ABS – QE.
- Knowledge on ISMS, MPP, Agile Scrum
|Job Category||Digital Engineering|