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Urgent Opening:: Validation Engineer :: @ Syntel

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 Urgent Opening:: Validation Engineer ::

Job Description

Roles and Responsibilities

NOTE - 5 years of solid full cycle validation engineer background

Kindly share updated resume Ze**************n@at*s.net

Desired Candidate Profile


  • At least 5 to 7+ years of experience in System Software Verification & Validation of embedded real-time software (new development as well as support project) in Healthcare and personal health industries.
  • Having experience in leading the design, build, validation and deployment of effective test automation solutions.
    SQA (CMMi level 3-5 Internal and external Auditing)
  • Experience on methodologies including Agile - Scrum and Waterfall models.
  • Experience in authoring key validation deliverables such as Validation Plan and Validation summary Reports.
  • Reviewing key validation deliverables IQ/OQ/PQ protocols and Execution and Traceability Matrix.
  • Expertise in Change management process and stage gating of changes across quality and production environments.
  • Instrumental in reviewing and updating Standard operating procedure, Work instructions for Change management and authoring process guidelines for various projects.
  • Expertise in development and manage GxP system lifecycle documentation including Validation Plan, URS, design specification, Test protocol (IQ/OQ/PQ,) RTM, Validation summary reports, Risk Assessment reports.
  • Implementation of Quality Systems and compliance with FDA 21 CFR Part 11(ER, ES and Audit Trail) and GAMP 5
  • Risk Assessment to define Validation strategy
  • Authoring key validation deliverables such as Validation Plan and Validation summary Reports
  • Review IQ, OQ and PQ execution.
  • Experience in managing Deviations
  • Ensure tool adherence and Data Integrity, across interfaces/systems -Azure DevOps/AWS cloud

Tools Expertise:

  • Change Management: ServiceNow
  • Solution Manager: CHARM
  • Validation Tool: ValGenesis
  • Document Management Tool: Agile Doc-ER, DocSpace
  • Test Management Tools: X-RAY, HPALM
  • Project Management: JIRA, Azure DevOps, AWS

Perks and Benefits


Job Classification

Industry: IT-Software, Software Services
Functional Area: IT Software - Application Programming, Maintenance,
Role Category: Programming & Design
Role: Programming & Design
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization
Post Graduation: Any Postgraduate in Any Specialization
Doctorate: Any Doctorate in Any Specialization

Contact Details:

Company: Syntel
Address: SDF IV,Unit 112,Seepz,Seepz Road,Andheri East, , , MUMBAI, Maharashtra, India
Location(s): Pune

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Keyskills:   PQ OQ Build Cloud URS IQ JIRA Gamp Azure Devops Gxp

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Syntel

Atos Syntel is a leading global provider of integrated information technology and knowledge process services. Atos Syntel helps global enterprises evolve the core by leveraging automation, scaled agile and cloud platforms to build efficient application development and management, testing and infr...