Computer Systems Validation Specialist
2 weeks ago
Katalyst Healthcares and Life Sciences is seeking a skilled Computer Systems Validation Specialist to join our team. As a CSV Validation Expert, you will be responsible for ensuring the integrity and compliance of our computerized systems. Your expertise in validation lifecycle management will be crucial in maintaining our high standards of quality and regulatory compliance. Key responsibilities include:
### Validation Activities
* Develop and execute test protocols and test scripts for computerized systems
* Author, review, and approve GDPs computer system lifecycle documentation
* Collaborate with project managers and CSV leads to ensure timely validation activities
### Regulatory Compliance
* Ensure compliance with regulatory requirements and standard best practices, including GLP/GMP, 21 CFR Part 11, Annex 11, and GAMP5
* Identify and mitigate risks associated with computerized systems
### Communication and Collaboration
* Work closely with cross-functional teams to ensure effective communication and collaboration
* Provide support for all CSV-related deviations, discrepancies, and change control documentation
### Requirements
* 3 to 5+ years of experience in computer systems validation
* Preferred MES/Delta experience
* Strong knowledge of regulatory requirements and standard best practices
* Excellent communication and collaboration skills
If you are a motivated and detail-oriented professional with a passion for validation and regulatory compliance, we encourage you to apply for this exciting opportunity. Please submit your application, including your resume and a cover letter, to [insert contact information].
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