Qualified Person - QP

Qualified Person - QP responsible for ensuring GMP compliance, facilitating site compliance with the company’s Quality Management system, and providing QA oversight and technical expertise.

Requirements

• Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF
• Review completed batch records and complete batch dispositions
• Develop and own the batch release process
• Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations
• Identify, communicate, and escalate quality and compliance risks
• Ensure changes are appropriately managed
• Approval of procedures and policies
• Work as part of the MeiraGTx team to undertake continuous improvement of business quality systems
• Advise and participate in projects from a quality assurance perspective
• Keep up to date with regulatory changes and developments
• Assist with regulatory inspections providing SME support
• Support self-inspection process, providing coaching to self-inspection auditors

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan