QC Compliance & Data Integrity Lead

Fastnet; Cork; On-site; EUR 70,000 - 100,000; Full time

Job summary

Fastnet in Cork is seeking an experienced QC professional to lead GMP compliance and data integrity within its pharmaceutical QC laboratory.

You will oversee analytical data review, ensure regulatory readiness and support continuous improvement across QC operations. A degree in Chemistry or Pharmaceutical Sciences, 5+ years in GMP QC labs, and Empower experience are required.

Qualifications

• Degree in Chemistry, Pharmaceutical Sciences or a related discipline.
• Minimum 5 years' experience in a GMP regulated pharmaceutical QC laboratory; API experience preferred.
• Strong knowledge of data integrity, QC compliance, investigations and regulatory inspections.

Responsibilities

• Oversee the review and release of QC analytical data for finished products, in-process materials and raw materials.
• Ensure compliance with GMP, data integrity principles and regulatory requirements.
• Coordinate laboratory investigations, CAPAs, SOP reviews and documentation compliance.
• Drive continuous improvement, inspection readiness and best practices across the QC laboratory.

Skills

GMP compliance

Data integrity

Leadership

Investigations

Quality control

Regulatory inspections

Empower

Education

Degree in Chemistry, Pharmaceutical Sciences or related

Tools

Empower

Job description

An excellent opportunity for an experienced QC professional to take a lead role in driving GMP compliance and data integrity within a pharmaceutical QC laboratory.

The successful candidate will oversee analytical data review, maintain regulatory standards and support continuous improvement across QC operations.

Key Responsibilities:

• Oversee the review and release of QC analytical data for finished products, in-process materials and raw materials.
• Ensure compliance with GMP, data integrity principles and regulatory requirements.
• Coordinate laboratory investigations, CAPAs, SOP reviews and documentation compliance.
• Drive continuous improvement, inspection readiness and best practices across the QC laboratory.

Key Requirements:

• Degree in Chemistry, Pharmaceutical Sciences or a related discipline.
• Minimum 5 years' experience in a GMP regulated pharmaceutical QC laboratory; API experience preferred.
• Strong knowledge of data integrity, QC compliance, investigations and regulatory inspections.
• Experience with QC laboratory systems such as Empower, along with strong communication and leadership skills.