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Computer System Validation Specialist
2 weeks ago
We are seeking a highly skilled professional to ensure the validation of computer systems in a regulated industry.
- Develop clear, concise reports and conduct thorough risk assessments and audits.
- Collaborate with cross-functional teams to implement process improvements and optimize system performance.
- Stay up-to-date with regulatory requirements and industry best practices.
Requirements:
- Bachelor's degree in a related field or equivalent.
- 5-8 years of experience in Computer System Validation/Quality Compliance.
- Strong knowledge of fundamental cGMP concepts and FDA regulations.
- Hands-on experience with EDMS and test management tools.
Preferred Qualifications:
- Experience working with medical devices, pharmaceuticals, or life sciences.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
- Ability to prioritize tasks and manage multiple projects simultaneously.
