Computer System Validation Specialist Job at JAF Consulting, Inc, Remote

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  • JAF Consulting, Inc
  • Remote

Job Description

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.

Job Tags

Remote job, Full time,

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