Senior QA - Materials & Supply Chain (GMP) Hybrid

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; Sur place; DKK 750 000 - 1 050 000; Plein temps

Avantages offerts par ce poste

Health insurance

Hybrid working

Canteen & Friday brunch

Résumé du poste

FUJIFILM Biotechnologies in Hillerød, Denmark, seeks a Senior QA Associate to provide quality oversight for Materials, Supply Chain, and Warehouse operations with a focus on material qualification and onboarding for GMP manufacturing.

You will own complex QA activities, partner with Operations, QA, QC, and Supply Chain, and drive improvements across systems and procedures while maintaining cGMP compliance and robust documentation practices.

Qualifications

• Bachelor’s or Master degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field with 7+ years in pharma/biotech QA.
• Deep knowledge of GMP quality systems and documentation control.
• Strong understanding of material qualification and onboarding for GMP manufacturing.

Responsabilités

• Lead QA material qualification and new material onboarding for GMP use; assess and approve changes, deviations, CAPAs.
• Provide QA support to materials, supply chain, and related activities with cGMP alignment.
• Conduct gemba walks and document observations; lead cross-functional improvement initiatives.

Connaissances

Cross-functional collaboration

Training & mentoring

Documentation practices

Quality mindset

Process improvement

Risk management

Formation

Bachelor’s or Master degree in Chemistry/Biology/Biochemistry/Pharmaceutical Sciences

Outils

ERP/MES/LIMS

eQMS

Description du poste

FUJIFILM Biotechnologies in Hillerød, Denmark, seeks a Senior QA Associate to provide quality oversight for Materials, Supply Chain, and Warehouse operations with a focus on material qualification and onboarding for GMP manufacturing.

You will own complex QA activities, partner with Operations, QA, QC, and Supply Chain, and drive improvements across systems and procedures while maintaining cGMP compliance and robust documentation practices.