Senior QC Lead — GMP Compliance & Lab Excellence

Aphex Group; Galway; On-site; EUR 70,000 - 95,000; Full time

Job summary

Aphex Group in Galway seeks a qualified leader for its Quality Control laboratory to ensure analytical testing of raw materials and finished products complies with GMP, GLP, and regulatory requirements (EU & US). You will support the Head of Quality to maintain readiness for inspections and continuous improvement.

You will oversee laboratory operations, investigations into OOS results, and method transfer, while managing a team and budgeting.

Qualifications

• Bachelor's degree in science.
• Minimum 5 years in a pharmaceutical environment with cGLP leadership and EU GMP/US FDA knowledge.
• Strong organisational, time management and prioritisation skills; excellent communication.
• Ability to lead a team with high ethical standards; proactive and flexible.
• Proficient in MS Office and data handling.

Responsibilities

• Test and ensure compliance with EU/US regulatory requirements and data integrity.
• Manage QC stability program, equipment calibration, and scheduling across sites.
• Lead investigations for OOS, equipment failures, and analytical errors.
• Oversee method transfer, development, validation, and GMP documentation.
• Lead, train, and develop laboratory personnel; report KPIs monthly.

Education

Bachelor's degree in science

Tools

MS Office

Job description

Aphex Group in Galway seeks a qualified leader for its Quality Control laboratory to ensure analytical testing of raw materials and finished products complies with GMP, GLP, and regulatory requirements (EU & US). You will support the Head of Quality to maintain readiness for inspections and continuous improvement.

You will oversee laboratory operations, investigations into OOS results, and method transfer, while managing a team and budgeting.