Overview
On Site
Full Time
Skills
Medical Devices
Verification And Validation
Manufacturing
ISO 9000
Testing
Business Requirements Gathering
Traceability Matrix
Release Notes
Regulatory Compliance
GAMP
Risk Assessment
Functional Requirements
Test Strategy
SOP
Training
Job Details
Responsibilities and requirements:
- 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics).
- Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements).
- Prepare, review functional requirements, design and testing documents.
- Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment, installation qualification, operational qualification, performance qualification, traceability matrix, project release notes, system certification summary).
- Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.
- Preparing trace matrix to ensure requirements are tested to meet the software intended use.
- Preparing risk assessment for functional requirement and provide testing strategy, implementing technical & procedural controls as part of mitigation.
- Preparing SOP/Work instruction for equipment's and software-based systems.
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