ERP (D365) Validation Consultant

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Quick Summary

Key Responsibilities

ERP Validation Planning and Execution: Develop, execute, and manage validation plans for Microsoft D365 implementations and upgrades to ensure regulatory compliance, particularly in the cloud.

Technical Tools

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Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Responsibilities

~1 min read

→ERP Validation Planning and Execution: Develop, execute, and manage validation plans for Microsoft D365 implementations and upgrades to ensure regulatory compliance, particularly in the cloud.
→Compliance with Regulatory Standards: Ensure D365 deployments meet all relevant regulatory standards, such as FDA 21 CFR Part 11, GxP, and GDPR, by conducting risk assessments, validation testing, and documentation reviews.
→Document Creation and Management: Create detailed validation documents, including validation plans, protocols (IQ, OQ, PQ), risk assessments, traceability matrices, and summary reports.
→Testing and Verification: Develop and execute test cases to verify system functionality, security, and compliance, addressing any discrepancies found in the validation process.
→User Training and Support: Provide training to end-users and project stakeholders on validation processes, standards, and best practices. Support troubleshooting of any validation-related issues during and after implementation.
→Continuous Improvement: Identify areas for improvement in validation methodologies and processes, including leveraging automation tools and advanced testing methods to improve efficiency.
→Collaboration: Work closely with cross-functional teams, including IT, QA, and operations, to support project goals, ensure smooth communication, and coordinate validation activities within project timelines.

Requirements

~1 min read

Education: Bachelor’s degree in Computer Science, Engineering, or a related field; relevant certifications in Microsoft D365 or ERP validation are a plus.
Experience: 3-5 years of experience in ERP validation, with at least 2 years focused on Microsoft D365 in a cloud environment, ideally within regulated industries.
Technical Skills:
- Proficiency in Microsoft D365 ERP functionality and cloud-based implementations.
- Strong understanding of regulatory standards such as FDA 21 CFR Part 11, GxP, GDPR, and ISO standards.
- Experience in cloud environments and cloud compliance standards.
- Familiarity with automated testing and validation tools.
Soft Skills:
- Strong problem-solving and analytical skills.
- Excellent communication and documentation skills.
- Ability to work independently and manage time effectively.