GMP QC Compliance Lead

MeiraGTx; Shannon; On-site; EUR 60,000 - 90,000; Full time

Job summary

MeiraGTx is seeking a QC compliance Specialist to ensure GMP-compliant activities within QC supporting the manufacture of gene therapy products in Ireland. You will review and approve QC documentation to support batch release and support the QC manager on additional tasks.

Responsibilities include creating, tracking and reporting QC KPI's, conducting audits, coordinating training, maintaining GMP data integrity, and driving continuous improvement within the Quality Control group.

Qualifications

• Minimum 2 years experience working in a GxP environment.
• Experience of quality documentation and approval.
• Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.

Responsibilities

• GMP Compliance activities.
• Support Compliance team as and when required.

Skills

Quality environment experience

Attention to detail

Problem solving

Leadership

Planning/organizing

Professionalism

Innovation

Oral communication

Written communication

Data integrity

GxP knowledge

Microsoft Office

Tools

Microsoft Office

Job description

MeiraGTx is seeking a QC compliance Specialist to ensure GMP-compliant activities within QC supporting the manufacture of gene therapy products in Ireland. You will review and approve QC documentation to support batch release and support the QC manager on additional tasks.

Responsibilities include creating, tracking and reporting QC KPI's, conducting audits, coordinating training, maintaining GMP data integrity, and driving continuous improvement within the Quality Control group.