
Validation Specialist
2 weeks ago
We are seeking a highly skilled professional to lead the validation of computer systems and ensure compliance with regulatory requirements.
This role requires expertise in validating EDMS, medical domains, and computer systems to meet FDA standards.
The ideal candidate will have hands-on experience in Computer System Validation/Quality Compliance in a regulated industry.
Key qualifications include:
- Developing clear, concise, and timely reports
- Working on complex projects with minimal guidance
- Handling multiple projects and meeting deadlines
- Managing priorities and workflow
Responsibilities include developing fundamental cGMP concepts, FDA/EMA regulations, QSR, and ISO 9001 Standards. Additionally, experience with EDMS and Test Management tools is essential.
A bachelor's degree in a related field and 5-8 years of experience are required for this position.
The selected candidate will be responsible for ensuring that all computer systems meet regulatory requirements and are compliant with FDA standards.
Our company is committed to delivering high-quality services and products. We strive to maintain the highest standards of quality and safety in our work.
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