This role is with an organization that focuses solely on software validation within the FDA regulated industries. They work closely with Microsoft VARs but they do not do any software implementation services.
Main focus is on Dynamics AX, GP, NAV as well as Dynamics 365 ERP. A successful candidate must have previous experience with Microsoft Dynamics and FDA regulatory requirements.
Some training will be provided during the initial onboarding process.
This is an hourly contract role for the duration of first 12 months, which could potentially lead to a full time role or a contract extension.
- Drafting and execution of IQ/OQ/PQ/DQ/UAT test scripts (positive and negative testing)
- Draft/Review User Requirements Specification
- Provide regulatory guidance and consulting to clients
- Draft Validation Test Plan
- Draft Validation Project Schedule
- Draft Incident (deviation) reports
- Interpret Microsoft Dynamics AX/Dynamics 365 user requirements
- Manage validation projects
- Execute validation projects in compliance with current quality systems regulations
- Assist clients with maintaining the validated state
- Conducting supplier audits
- Review functional design requirements and customizations
- Review system configuration
- Participation in external audits as required.
- Provide recommendations on computer systems validation for pharma, medical device and biotech as well as other life sciences companies
- Must have advanced working knowledge of Microsoft Dynamics 365/AX/GP/NAV, SAP B1, Oracle e-Business, Oracle Fusion Cloud and other enterprise systems
- Must have deep domain knowledge of life sciences processes and validation testing methodologies
- Must have over 10+ years of enterprise computer systems validation testing experience
- Excellent interpersonal skills
- Ability to draft clear validation test scripts
- 21 CFR Part 11, Annex 11, GAMP 5, and cGMP knowledge is a must.
- Must be able to effectively communicate to Senior level officials
- Must have demonstrable excellent writing skills
- Advanced working knowledge of Microsoft Office tools including Microsoft Word/Excel/PowerPoint, Visio and Microsoft Project
- Must have practical experience with FDA CSV audits (be prepared to discuss at interview)
- Must be flexible (ability to work overtime if required)
- Practical, hands-on experience using automated testing tools (be prepared to discuss at interview)
- Must have advanced skills working remotely
The successful candidate may work remotely. The opportunity is immediate.
Contract length: 12 months
Job Types: Full-time, Contract
Pay: $60.00 - $70.00 per hour
- 8 hour shift
- Monday to Friday
- FDA regulations: 5 years (Required)
- Microsoft Dynamics ERP: 3 years (Required)
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