Quality Line Specialist

About the role

The Quality Line Specialist will oversee all quality aspects of a manufacturing product line, ensuring compliance with GMP standards and driving continuous improvement. You will act as the first line of response for quality emergencies and collaborate closely with cross‑functional teams.

Key responsibilities

• Ensure compliance with work instructions and conduct regular GMP audits on the production line.
• Manage quality holds, lead root‑cause investigations for defects and non‑conformities, and open non‑conformity reports when needed.
• Maintain and update risk analyses, PFMEA, and ensure they reflect current processes.
• Drive CAPA implementation for operational quality issues and create quality dashboards with KPI trend analysis.
• Lead process validation, change control, and update VMP documentation for significant process changes.
• Participate in cross‑functional process validation, change control, and worst‑case scenario definition.
• Coach production team leaders on first‑level investigations and ensure adherence to work instructions and GMP.

Required profile

• Proven experience in a quality role within a regulated manufacturing environment.
• Strong knowledge of GMP, quality documentation, and audit procedures.
• Ability to lead investigations, perform risk assessments, and manage CAPA cycles.
• Excellent analytical skills with a focus on data‑driven decision making.

Required skills

• GMP compliance
• Root Cause Analysis
• PFMEA
• CAPA management
• Process Validation
• Change Control