GMP QA Specialist - Batch Release & CAPA Expert

Telix Pharmaceuticals Limited; Herstal; Hybride; EUR 50 000 - 70 000; Plein temps

Avantages offerts par ce poste

Competitive salaries

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Paid wellness days

Support for learning and development

Résumé du poste

Telix Pharmaceuticals Limited in Herstal, Belgium, seeks a Quality Assurance Associate to support GMP-compliant quality management during commercial-scale-up across Europe, expanding MAH, secondary packaging and distribution operations.

The role requires a Bachelor's in science and 2+ years in a regulated quality role; English and French fluency are essential. The position reports to the local Senior Quality Assurance Manager and offers hybrid work options.

Qualifications

• Bachelor’s degree required; orientation in pharmacy, biochemistry or science preferred.
• 2+ years of quality experience in a regulated industry.
• Knowledge of EU and USA regulations.
• English and French fluency.

Responsabilités

• Adhere to GMP policies and Telix QMS requirements.
• Prepare, review and approve documents within QMS/eQMS and Master Control.
• Maintain quality system registers and provide training on Telix QMS.
• Participate in deviations, investigations, CAPA, change control and complaint reports.
• Support internal quality audits and report findings under Senior QA Manager guidance.
• Manage supplier quality audits, supplier quality agreements and CMOs compliance.
• Collaborate with production to ensure quality across operations and batch records.
• Support batch release activities for commercial and clinical products as needed.
• Identify system/process gaps and drive corrective/preventive actions.
• Engage in continuous professional development and learning.

Connaissances

GMP understanding

Quality management

Document review

Cross-functional collaboration

Communication skills

Adaptability

Continuous learning

Team collaboration

Formation

Bachelor's degree in pharmacy/biochemistry/science

Outils

eQMS

MasterControl

Description du poste

Telix Pharmaceuticals Limited in Herstal, Belgium, seeks a Quality Assurance Associate to support GMP-compliant quality management during commercial-scale-up across Europe, expanding MAH, secondary packaging and distribution operations.

The role requires a Bachelor's in science and 2+ years in a regulated quality role; English and French fluency are essential. The position reports to the local Senior Quality Assurance Manager and offers hybrid work options.