Remote Quality Engineer - QMS & Compliance Lead

BVB Labcorp BV; Mechelen; Hybride; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Remote working

Résumé du poste

Labcorp seeks an onsite Quality Engineer - Qualified Person to join our brand new CMC facility in Mechelen, Belgium. This role centers on implementing and maintaining a robust quality management system that meets domestic and international regulations, while coordinating CAPAs, change controls and regulatory inspections.

The successful candidate will lead QA activities, supervise a segment of the QA team, and ensure validation/qualification of facilities, utilities and computer systems in line

Qualifications

• Certified Qualified Person by FAMHP is required.
• Master degree in Pharmacy is required.
• 3+ years of quality-related work experience.

Responsabilités

• Supports implementation of a quality management system complying with domestic and international regulations.
• Ensures local compliance with QMS requirements.
• Oversees CAPA, Change Controls, Vendor Management and complaint handling.
• Leads QA team activities, including training and development.
• Represents QA on projects and supports regulatory inspections.

Connaissances

Quality management

Regulatory compliance

Leadership

Formation

Master degree in Pharmacy

Certified Qualified Person by FAMHP

Description du poste

Labcorp seeks an onsite Quality Engineer - Qualified Person to join our brand new CMC facility in Mechelen, Belgium. This role centers on implementing and maintaining a robust quality management system that meets domestic and international regulations, while coordinating CAPAs, change controls and regulatory inspections.

The successful candidate will lead QA activities, supervise a segment of the QA team, and ensure validation/qualification of facilities, utilities and computer systems in line