CSV Validation Specialist
4 days ago
Job Title: CSV Validation Specialist
Job Summary:
Amaris Consulting is seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation within the pharmaceutical industry.
Key Responsibilities:
- Develop and implement CSV strategy and validation plans for computerized systems.
- Create and review validation documentation, including validation protocols, test scripts, and traceability matrices.
- Execute validation protocols and test scripts, documenting test results, deviations, and issues.
- Implement and manage change control processes for computerized systems.
- Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
Qualifications:
- Bachelor's degree in computer science, engineering, pharmaceutical sciences, or a related field.
- Strong knowledge of pharmaceutical regulations and quality standards.
- Experience in computer systems validation within the pharmaceutical industry.
- Proficiency in validation tools, methodologies, and validation testing techniques.
- Excellent project management skills and attention to detail.
- Effective communication and collaboration skills.
Amaris Consulting is an equal-opportunity workplace committed to promoting diversity and creating an inclusive working environment.
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