Computer System Validation Specialist (Remote)

Company Description

JAF Consulting, Inc. is a leading consultancy specializing in Global Quality and Regulatory Compliance Services for industries such as Pharmaceutical, Life Science, Nutraceutical, and Medical Devices. We offer Quality Assurance as a Service (QAaaS) and provide a range of services including Computer & Process Validation, GLP, GMP, and GCP QA, Quality Management, Auditing & Assessment, and Training & Education. Our mission is to deliver innovative, pragmatic, and top-quality services at reasonable prices, ensuring that our clients achieve and maintain compliance with relevant regulations and standards.

We are currently seeking a full-time remote Computer Validation Specialist. This role entails validating both laboratory and enterprise systems and ensuring sustained quality and compliance.

As a Computer Validation Specialist, you will:

• Collaborate with client experts to document requirements by researching existing instrument/departmental documentation.
• Develop validation deliverables to support compliance programs.
• Formulate testable requirements for GLP, GMP, and GCP laboratory equipment, automation systems, or enterprise computerized systems.
• Address open compliance issues through procedural controls.
• Coordinate and assist in review processes with the Project Lead and QA Specialist.

Qualifications for this role include:

• 7-10 years of experience in the Pharmaceutical and Life Science industry.
• Knowledge of FDA regulations, particularly 21 CFR Part 58, 21 CFR Part 210 & 211, ICH E6(R3), and 21 CFR Part 11.
• Familiarity with Quality Control (GMP), GLP, and GCP processes.
• Ability to work independently and remotely.
• Strong communication skills across all corporate levels.
• Excellent analytical, interpersonal, and written/verbal communication skills.
• Experience collaborating with project teams and managing multiple projects across functional areas.