
System Validation Specialist
9 hours ago
We are seeking a skilled professional to join our team as a Computer System Validation Engineer.
The ideal candidate will have a strong understanding of computer system validation principles and regulations.
- A bachelor's degree in a related field or equivalent is required.
- The candidate should have 5-8 years of experience in computer system validation/quality compliance in a FDA regulated industry, with a focus on GxP systems.
- They should possess fundamental knowledge of 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 is essential.
- Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools is required.
- Understanding of FDA's recent guidance on transition of CSV to CSA is beneficial.
- Excellent written and oral communication skills are necessary.
The successful candidate will be able to develop clear, concise, and timely reports, work on complex projects with minimal guidance, handle multiple projects and meet deadlines, manage priorities and workflow, and demonstrate versatility, flexibility, and a willingness to work within constantly changing priorities.
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