JAF is expanding our team! If you have the following skills, with 3-10 years experience, we would love to meet with you:

  • Experience and understanding US FDA GLP, GMP and/or GCP regulations
  • Experience and understanding of Good Automated Manufacturing Practices (GAMP 5), Computer Software Assurance (CSA), Analytical Instrument Qualification (AIQ), Manufacturing Systems Lifecycle (MSL) and other computer system validation methodologies.
  • Experience working with project teams and developing testable requirements for GLP, GMP, and GCP laboratory equipment, automation systems and computerized systems
  • Experience creating validation documents (for Waterfall, Agile, RAD methodologies)
    • GxP / Regulatory Assessment
    • Validation Master Plan
    • User Requirement Specification
    • Functional Requirement Specification
    • Functional Risk Assessment tool and report
    • Configuration Specification / Detailed Design Specification
    • Installation / Operational / Performance Qualification protocols
    • Requirement Traceability Matrix
    • Standard Operating Procedures
    • Validation Summary Report
  • Experience writing non-validation technical documents.
  • Experience managing multiple projects in different functional area.
  • Experience conducting GLP, GMP, and GCP adults
  • Positions are all US based. Although a remote position, a candidate must reside in the United States.

Please send your resume/CV with salary requirements to info@jafconsulting.com