GMP QA Associate — Biologics Manufacturing (Leiden)

Oxford Global Resources; Leiden; In loco; EUR 42.000 - 67.000; Tempo pieno

Vantaggi offerti da questo lavoro

Excellent secondary benefits

Biologics manufacturing environment

Descrizione del lavoro

Oxford Global Resources is seeking a QA Associate for a leading international biopharmaceutical company in the Leiden region. The role focuses on ensuring GMP and internal quality standards on the manufacturing floor, leading deviation investigations, and driving CAPA to improve quality performance.

The successful candidate will review change control documentation, support regulatory inspections and audits, and collaborate with cross-functional teams to maintain site-wide GMP compliance across

Competenze

• Hands-on experience in Quality Assurance within a pharmaceutical or regulated environment.
• Solid understanding of GMP regulations and quality standards.
• Experience with investigations, risk assessments and problem-solving methodologies.
• Fluent in Dutch and English.

Mansioni

• Provide GMP and quality guidance for routine and non-routine operations.
• Drive investigations, identify root causes, and ensure timely CAPA completion.
• Review and approve change control documentation.
• Support regulatory inspections and quality audits.
• Collaborate with cross-functional teams to maintain GMP compliance across projects and site changes.
• Evaluate and approve validation, stability, and other GMP-related protocols and reports.
• Contribute to Quality Risk Management activities and investigation workshops.

Conoscenze

Quality Assurance experience

GMP knowledge

Root cause analysis

CAPA

Investigations

Dutch and English fluency

Formazione

Life Sciences / Chemistry / Pharmacy degree

Descrizione del lavoro

Oxford Global Resources is seeking a QA Associate for a leading international biopharmaceutical company in the Leiden region. The role focuses on ensuring GMP and internal quality standards on the manufacturing floor, leading deviation investigations, and driving CAPA to improve quality performance.

The successful candidate will review change control documentation, support regulatory inspections and audits, and collaborate with cross-functional teams to maintain site-wide GMP compliance across