QA Associate

Oxford Global Resources; Leiden; Presencial; EUR 42.000 - 67.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Excellent secondary benefits

Biologics manufacturing environment

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance experience

GMP knowledge

Root cause analysis

CAPA

Investigations

Dutch and English fluency

Educación

Life Sciences / Chemistry / Pharmacy degree

Descripción del empleo

For a leading international biopharmaceutical company in the Leiden region, we are looking for a QA Associate to join their growing team!

Job Description

Our client is a globally recognized biopharmaceutical manufacturer specializing in the development and production of innovative biological therapies. The organization operates state-of-the-art manufacturing facilities and is committed to continuous improvement, operational excellence, and delivering high-quality medicines to patients. As a QA Associate, you will be the person responsible for overseeing that processes in the floor are up to GMP and other internal quality standards. You will take deviations and non conformances and lead investigations to result in the improvement of the quality performance.

Responsibilities

• 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.

Profile

• Degree in Life Sciences, Chemistry, Pharmacy, or similar, with relevant industry experience (2-6 years).
• Hands-on experience in Quality Assurance within a pharmaceutical or regulated environment.
• Solid understanding of GMP regulations and quality standards.
• Background in investigations, risk assessments, and problem-solving methodologies.
• Skilled in root cause analysis and CAPA-driven quality improvement.
• Fluent in both Dutch and English.

Employment Conditions

• Start through Oxford Global Resources with the possibility of extension
• Salary: €3,800 - €6,000 gross per month, depending on experience
• 12-month contract with potential for extension
• Excellent secondary benefits
• Opportunity to work in a highly advanced biologics manufacturing environment
• Region: Leiden

Reference: 27741