Quality Investigator & CAPA Lead (GMP/QA)

Real; Leiden; On-site; EUR 60,000 - 90,000; Full time

Job summary

Real is seeking an experienced Quality Specialist to strengthen its Quality Control organization within a GMP-regulated environment. You will lead investigations, perform root cause analyses, and coordinate CAPAs across QA, manufacturing, and regulatory teams.

Join a global biopharmaceutical setting focused on continuous improvement, quality systems, and compliance with FDA/EMA guidelines. Excellent analytical and communication skills in English are essential.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Biotechnology, or related field.
• 3-5+ years in Quality Assurance, Quality Control, Compliance, or related pharma environment.
• Experience with investigations, deviations, non-conformances, and CAPA.
• Strong GMP knowledge and pharmaceutical quality systems experience.
• Experience with Quality Management Systems (QMS).
• Strong analytical, problem-solving, and stakeholder management skills.
• Excellent English communication.

Responsibilities

• Lead quality investigations and non-conformance records.
• Perform root cause analyses and implement CAPAs.
• Assess quality events for impact on product quality and compliance.
• Ensure timely documentation of investigations and quality records.
• Collaborate with cross-functional stakeholders to resolve issues.
• Support internal audits, inspections, and quality assessments.
• Monitor quality trends and identify process improvements.
• Drive continuous improvement of quality systems and processes.
• Contribute to training related to investigations and GMP compliance.

Skills

Quality Assurance

Quality Control

CAPA management

GMP compliance

QMS

Analytical thinking

Stakeholder management

Communication in English

Education

Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences/Biotechnology

Job description

Real is seeking an experienced Quality Specialist to strengthen its Quality Control organization within a GMP-regulated environment. You will lead investigations, perform root cause analyses, and coordinate CAPAs across QA, manufacturing, and regulatory teams.

Join a global biopharmaceutical setting focused on continuous improvement, quality systems, and compliance with FDA/EMA guidelines. Excellent analytical and communication skills in English are essential.