Compliance- SQA

Full Time
Bangalore
Posted 4 weeks ago

Job ID:R1427-0812-12120-SQ

Role Compliance- SQA

No of Positions  1

Experience  5-10 Years
Location  Bangalore

Technical Competencies- SDLC Process, Compliance Knowledge, Agile, Scrum, Technical Documentation, Project Risk Assessment

Responsibilities

  • 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

Requirements

  • 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 Features

Job CategoryDigital Engineering

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