GCP QA Standards and Training Consultant

GCP QA Standards and Training Consultant

Term: 1 year

Industry: Pharma

Location: Client in Northern NJ, this role is remote

Ideally able to go to office on occasion

Description:

The Consultant, GCP Quality Assurance will assist the Head of CQA in revising the CQA Standards/SOPs, upskilling auditing practices for CQA staff, develop & deliver training (where applicable).

Tasks
1. Perform gap analysis of current CQA Standards and CQA staff skill set
2. Develop plan for revision of current Processes/ SOPs
3. Develop roadmap for Skill set training
4. Revise or create new SOPs
5. Develop CQA training materials
6. Deliver training

Requirements

  • Minimum of 5-8 years of Clinical Quality Assurance and auditing experience
  • Experience in SOP development
  • Experienced trainer
  • Experience with inspection management
  • Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems

Location: remote

  • Accepted file types: doc, pdf, txt, docx.