This is a fully remote position, open to applicants in United States.

📋 Description

• Plan, implement, and oversee validation activities for computerized systems in compliance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and relevant GxP regulations.

• Create and uphold validation documentation, including Validation Plans, User Requirements Specifications, Functional Specifications, Risk Assessments, Test Cases, Traceability Matrices, and Validation Summary Reports.

• Conduct system risk assessments to establish validation scope and testing needs.

• Ensure systems maintain their validated status through regular reviews, change control, and lifecycle management.

• Assess software releases, upgrades, patches, and configuration changes for their validation implications.

• Formulate standard operating procedures, work instructions, and validation templates.

• Engage in regulatory inspections, customer audits, and internal quality assessments.

• Collaborate with Quality Assurance, Information Technology, Clinical Operations, and business stakeholders to ensure system efficacy, data integrity, security, and regulatory adherence.

⛳️ Requirements

• Comprehensive understanding of GAMP 5 guidelines, FDA 21 CFR Part 11, ICH E6(R3) Good Clinical Practice, EU CTR 536/2014, data integrity principles, and software development life cycles.

• Highly organized with the ability to manage multiple priorities in a fast-paced environment.

• A minimum of a high school diploma or GED is required.

• At least 4 years of direct CSV experience in a regulated life sciences or clinical research setting.

• Practical experience in validating life sciences/clinical applications (e.g., QMS, CTMS, LIMS, eSource, eBinder).

• Capable of using keyboards and other computer equipment.

• Care Access is currently unable to sponsor work visas.