Computer Systems Validation
Gap Assessment
Remediation Planning
Training (ICH GCP, Part 11, CSV, etc)
Network Qualification
SOP and Policy Creation

Typical projects include:

• Writing validation plans, qualification plans, summaries, testing documents, assessments and/or training material.
• Executing validation protocols.
• Conducting training.
• Advising on validation strategy or compliance issues.
• Interaction with validation, quality assurance and IT staff at all levels.

All consultants must:

• Have excellent organizational, written & verbal skills
• Be detail oriented
• Have a strong work ethic
• Be a quick learner
• Be able to hit the ground running on new systems
• Be dedicated to producing a quality deliverable
• Be client centric
• Have excellent judgment & problem solving skills
• Be willing to travel
• Be a self-manager
• Have working knowledge of industry regulation, guidance and standards (including GAMP, General Principles of Software Validation, & 21 CFR 11, 210, 211, 820, etc)

Send your resume to: recruiting@21CFRconsulting.com in TXT, PDF or DOC format.