Cork-Based GMP Quality Specialist – API Release & CI

LEO Pharma UK/IE; Cork; On-site; EUR 45,000 - 65,000; Full time

Job summary

A global leader in medical dermatology in Cork is seeking an experienced Quality Specialist. The role involves certifying drug substances for release, managing deviations, and driving quality improvement across API Manufacturing. Ideal candidates will have a Bachelor's degree in a relevant field and significant experience in pharmaceutical manufacturing, along with knowledge of GMP and QMS. A collaborative mindset is essential in this dynamic environment.

Benefits

Professional growth opportunities

Supportive team environment

Collaborative culture

Qualifications

• Significant experience in pharmaceutical manufacturing, ideally in API production.
• Experience with quality systems including CAPA and Change Control.
• Familiarity with regulatory submissions and Annual Product Quality Reviews (PQR).

Responsibilities

• Conducting batch release in line with cGMP and internal QA systems.
• Reviewing and approving quality documentation, SOPs, and testing methods.
• Leading quality improvement and global projects.
• Coordinating with internal teams and external partners.

Skills

Knowledge of Good Manufacturing Practice (GMP)

Quality Management (QMS)

Regulatory Compliance

Solid understanding of pharmaceutical production processes

Root cause analysis

Cross-functional collaboration

Education

Bachelor’s Degree in Chemistry, Pharmaceutical Science or Biotechnology

Tools

Veeva Vault

LIMS

ERP

Job description

A global leader in medical dermatology in Cork is seeking an experienced Quality Specialist. The role involves certifying drug substances for release, managing deviations, and driving quality improvement across API Manufacturing. Ideal candidates will have a Bachelor's degree in a relevant field and significant experience in pharmaceutical manufacturing, along with knowledge of GMP and QMS. A collaborative mindset is essential in this dynamic environment.