
System Assurance Specialist
3 days ago
System Assurance Specialist
About this critical role:
The System Assurance Specialist plays a key part in ensuring the quality and compliance of our systems.
Key Responsibilities:
- Develop and implement assurance plans for computer systems and equipment to guarantee high-quality performance and reliability
- Ensure adherence to regulatory requirements, including FDA guidelines and international standards such as GxP system requirements
- Manage electronic documentation and test management tools effectively
- Collaborate with cross-functional teams to achieve project objectives and deliverables
Requirements:
- Bachelor's degree in a relevant field or equivalent academic background
- 5-8 years of experience in System Assurance/Quality Compliance in a regulated industry, preferably within the FDA-regulated sector
- Strong knowledge of FDA regulations, QSR, 21 CFR Part 820, and ISO 9001 Standards
- Excellent written and oral communication skills
Preferred Skills:
- Hands-on experience with Microsoft Office and Visio
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