Senior Validation Specialist
3 weeks ago
About the role at RxCloud
Job Summary
RxCloud is seeking a highly experienced Computer Systems Validation Lead to join our team. As a key member of our validation team, you will be responsible for ensuring the scalability and maintainability of our validation documentation and testing protocols.
Key Responsibilities
- Develop and implement scalable validation strategies, documents, and testing protocols to ensure continuous compliance.
- Perform document reviews and provide feedback to ensure high-quality validation documentation.
- Collaborate with cross-functional teams to develop and implement validation plans and protocols.
- Provide expertise on FDA 21 CFR Part 11 and other regulatory requirements.
- Validate Enterprise systems, including SAP and MES systems, and Life sciences systems, such as Veeva, Trackwise, and Argus.
- Stay up-to-date with industry trends and best practices in computer systems validation.
- Develop and maintain relationships with key stakeholders, including business leaders and technical teams.
Requirements
- At least 10 years of experience in computer systems validation, including development of scalable validation strategies and documents.
- At least 7 years of prior experience in computer systems validation within GMP/GxP regulated environments.
- Proven experience developing full validation documentation and testing protocols within the SDLC phases.
- Experience with test management tools, including Microfocus ALM and ValGenesys.
- Broad understanding of CSA and its applications.
Preferred Qualifications
- Experience with Life sciences systems, such as Clinical and Quality systems.
- Knowledge of industry trends and best practices in computer systems validation.
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