Senior QC Leader - GMP/GLP Lab Operations

Chanelle Pharma; Loughrea; On-site; EUR 85,000 - 120,000; Full time

Job summary

Chanelle Pharma in Loughrea, Ireland seeks an experienced QC Manager to lead our Quality Control laboratory operations. You will ensure timely testing and release of materials and finished products while maintaining GMP, GLP and data integrity.

You will supervise the laboratory team, drive continuous improvement and ensure compliance with EU and US regulatory requirements. The role collaborates with the Head of Quality and involves audits and regulatory inspections.

Qualifications

• Bachelor’s degree in a science-based discipline.
• Minimum of 5 years in a pharmaceutical environment.
• Strong computer skills in MS Office.
• Experience in a pharmaceutical cGLP environment; knowledge of EU GMP and US FDA guidelines.

Responsibilities

• Lead and develop the QC laboratory team to ensure timely testing and release of materials and finished products.
• Ensure testing complies with EU and US regulatory requirements and data integrity standards.
• Maintain QC stability testing program and review laboratory results, protocols and reports.
• Provide technical guidance for equipment and calibration issues and investigate out-of-spec results.
• Oversee method transfer, development and validation in line with regulatory procedures.
• Review SOPs, COIs and test methods, and manage KPI reporting and lab performance.

Skills

Leadership

GMP

GLP

Data integrity

Regulatory compliance

MS Office

Education

Bachelor’s degree in science

Job description

Chanelle Pharma in Loughrea, Ireland seeks an experienced QC Manager to lead our Quality Control laboratory operations. You will ensure timely testing and release of materials and finished products while maintaining GMP, GLP and data integrity.

You will supervise the laboratory team, drive continuous improvement and ensure compliance with EU and US regulatory requirements. The role collaborates with the Head of Quality and involves audits and regulatory inspections.