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System Validation Specialist
3 weeks ago
About our company:
We are a technology firm that provides IT, consulting and business process services.
- Essential Qualifications:
An ideal candidate has 5-8 years hands-on experience in Computer System Validation/Quality Compliance within a regulated industry with a focus on GxP systems.
The candidate must have knowledge of fundamental cGMP principles and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
The candidate should have strong knowledge of manufacturing processes, process validation, computer and equipment validation, and GMPs.
The ideal candidate should also have hands-on experience in EDMS & Test Management tools.
The candidate should be able to understand recent FDA guidance on CSV to CSA transition.
The candidate should have the ability to develop clear, concise, and timely reports. Excellent written and oral communication skills are required.
The candidate should be able to work on complex projects with general direction and minimal guidance.
The candidate should be able to handle multiple projects and meet deadlines.
The candidate should be able to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities are required.
