
System Validation Specialist
4 days ago
Job Description:
About a leading Indian multinational technology company based in Bengaluru, they provide IT and consulting services.
- Mandatory skills:
- 5-8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
- Fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
- Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
- Hands-on experience in EDMS & Test Management tools.
Key Responsibilities:
- Develop clear, concise reports.
- Excellent written and oral communication skills.
- Ability to work on complex projects.
- Handle multiple projects and meet deadlines.
- Manage priorities and workflow.
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