What are the responsibilities and job description for the Validation specialist position at JAF Consulting, Inc?
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.
- 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.
Last updated : 2024-11-23