Job Title: Computer System Validation (CSV) Specialist
Job Summary:
The Computer System Validation (CSV) Specialist is responsible for ensuring that computer systems used in various industries, such as pharmaceuticals, healthcare, and manufacturing, are validated to meet regulatory requirements and industry standards. They will work closely with cross-functional teams to test, document, and maintain computer systems in compliance with regulations such as 21 CFR Part 11 and Annex 11.
Responsibilities and Duties:
1. Develop and execute validation protocols for computer systems, including software, hardware, and network infrastructure.
2. Conduct risk assessments and gap analyses to identify areas of non-compliance.
3. Collaborate with stakeholders to define validation requirements and implement solutions.
4. Perform qualification tests, such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
5. Document validation activities and maintain validation documentation throughout the system lifecycle.
6. Provide support during regulatory inspections and audits.
7. Stay up-to-date on industry best practices and regulatory updates related to CSV.
Qualifications and Skills:
1. Bachelor's degree in Computer Science, Engineering, or related field.
2. Minimum of 3 years of experience in computer system validation.
3. Knowledge of FDA regulations, GMP guidelines, and industry standards.
4. Experience with validation tools and methodologies.
5. Strong analytical and problem-solving skills.
6. Excellent communication and teamwork abilities.
7. Attention to detail and the ability to work independently.
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