
Computer System Validation Specialist
2 days ago
The selected candidate will work on complex projects with general direction and minimal guidance.
We require an experienced engineer to validate computer systems, ensuring compliance with regulatory requirements.
- A bachelor's degree in a related field or equivalent is required.
- Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations (QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards).
The ideal candidate will have 5+ years of experience in computer system validation/quality compliance within the FDA-regulated industry.
About this role:
This job involves hands-on experience in EDMS (Electronic Document Management system) & Test Management tools, as well as understanding of FDA's recent guidance on transition of CSV to CSA.
What we're looking for:
- Excellent written and oral communication skills.
- Ability to work independently with minimal guidance.
Why choose us?
This role offers a challenging opportunity to work on complex projects and develop your career in a dynamic environment.
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