
Computer Systems Specialist
3 days ago
About People Prime Worldwide:
Our company is a global leader in the technology industry, providing innovative solutions to our clients.
The position of Validation Engineer plays a crucial role in ensuring the quality and reliability of our systems.
- Key Responsibilities
- Develop and implement validation protocols for computer systems and equipment
- Conduct risk assessments and develop mitigation strategies to ensure compliance with FDA regulations
- Collaborate with cross-functional teams to identify and resolve technical issues
- Provide clear and concise documentation of validation activities and results
Requirements
- 5-8 years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences)
- Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards
- Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools
- Excellent written and oral communication skills
- Ability to work on complex projects with general direction and minimal guidance
Working Environment
Our team is dynamic and fast-paced, with a focus on delivering high-quality results under tight deadlines. We offer a collaborative and supportive environment that encourages professional growth and development.
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