Location: Raleigh, North Carolina- Hybrid
The Validation Specialist, Regulatory is responsible for implementing GxP computerized systems for the R&D IT department. A successful candidate will have recent CSA experience, an understanding of relevant US and EU regulations, and familiarity with validating SaaS applications, and AI models. Direct experience with electronic Instructions For Use and electronic Prescribing Information, Regulatory Intelligence, and Regulatory Submission and Deficiency management are preferred.
Validation Strategy
Subject matter expertise with GAMP 5 principles, US Code of Federal Regulations, and EU Annex 11 regulations
Subject matter expertise in computer software assurance (CSA) principles
Ability to review processes and procedures and implement GxP computerized software in a compliant manner
Ability to lead and facilitate meetings, interact with relevant stakeholders, and build strong relationships
This activity constitutes ~10% of the job description
Technical Writing
Ability to write validation documents to support the implementation of software applications including change controls, validation plans, user requirements, and testing documentation
Ability to write training documentation, User and Admin SOPs, as applicable
Experience with electronic validation applications preferred
This activity constitutes ~40% of the job description
System Implementation
Ability to implement GxP computerized systems, including project management configuration, user acceptance testing, and hypercare
Ability to drive user adoption of the new application through training and change management
Ability to maintain the validated state of applications in accordance with policies and procedures
This activity constitutes ~50% of the job description
Technical & Functional Skills
Experience with Computer System Validation, Computer Software Assurance and GxP relevant applications
Experience with writing standard operating procedures, validation deliverables, training material
Experience running projects and strategy initiatives
Minimum Qualifications
Bachelor's Degree in Computer Science / Information Systems or related discipline
3 5 years of experience in a position of equal scope and responsibility
Experience in the pharmaceutical or medical device industry
Preferred Qualifications
Experience with Medical Device Regulatory Submissions and applications used by Regulatory Affairs teams
Experience with CSA validation of SaaS applications
Experience with CSA or CSV validation of AI models
Physical Requirements
This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.
ravi.kumar@stellentit.com
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