Clinical Quality Assurance Advisor

Job Description

Job Summary:

• 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).

Duties and Responsibilities:

• Perform gap analysis of current CQA Standards and CQA staff skill set.
• Develop plan for revision of current Processes/ SOPs.
• Develop roadmap for Skill set training.
• Revise or create new SOPs.
• Develop CQA training materials.
• 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.