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