GMP Biologics QA Specialist - Hybrid (Netherlands)

Discover International; Amsterdam; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Discover International is seeking a Quality Assurance Specialist to support a GMP-regulated biologics environment in the Netherlands. The role focuses on deviations, investigations, CAPA and ongoing GMP compliance, collaborating with Manufacturing, QC, Engineering and other technical functions.

The ideal candidate will have 4–5 years of pharma/biopharma QA experience, a Life Sciences degree, and hands-on TrackWise or similar QMS knowledge.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, Pharmacy, Biochemistry, Engineering or a related scientific discipline.
• Approximately 4–5 years of relevant pharmaceutical/biopharmaceutical QA experience.
• Strong practical experience managing or supporting deviations and investigations.
• Good understanding of GMP and pharmaceutical Quality Systems.
• Experience with CAPA, change control and risk assessment.
• TrackWise experience is highly desirable; experience with another electronic QMS can also be considered.
• Experience supporting manufacturing operations within a regulated environment.
• Biologics/mAb manufacturing experience is a strong advantage.
• Comfortable working cross‑functionally and challenging quality issues when required.
• Strong analytical, problem‑solving and communication skills.
• Fluent professional English required; Dutch would be advantageous.
• Able to work independently while operating effectively within a wider Quality organisation.
• Comfortable working in a hybrid model with 2 days per week on site in the Netherlands.

Responsibilities

• Lead QA oversight for deviations, incidents and quality investigations, ensuring root‑cause analysis, impact assessment and timely closure.
• Review and assess CAPAs, ensuring actions are appropriate, effective and completed within timelines.
• Support and review change controls, assessing GMP impact and ensuring proper approvals.
• Provide QA support to upstream and downstream manufacturing operations and review GMP documentation.
• Support day‑to‑day GMP compliance across manufacturing, QC and supporting functions.
• Review batch documentation, SOPs, protocols, reports and other GMP documentation for completeness and accuracy.
• Use and maintain electronic Quality Management Systems (TrackWise) for deviations, CAPAs, change controls.
• Participate in internal, customer and regulatory audits/inspections, including preparation and follow‑up.
• Support risk assessments, quality impact assessments and root‑cause analysis for issues.
• Monitor quality trends and contribute to continuous improvement initiatives.
• Work closely with cross‑functional teams to resolve quality issues.
• Support the development and delivery of GMP/quality training as required.
• Contribute to inspection readiness and a strong quality culture.

Skills

CAPA & root-cause analysis

Change control

Risk assessment

QMS / documentation

GMP / GxP knowledge

Analytical problem-solving

Communication skills

Cross-functional collaboration

Fluent English

Education

Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Chemistry, Pharmacy, Biochemistry, Engineering or related field

Tools

TrackWise

Job description

Discover International is seeking a Quality Assurance Specialist to support a GMP-regulated biologics environment in the Netherlands. The role focuses on deviations, investigations, CAPA and ongoing GMP compliance, collaborating with Manufacturing, QC, Engineering and other technical functions.

The ideal candidate will have 4–5 years of pharma/biopharma QA experience, a Life Sciences degree, and hands-on TrackWise or similar QMS knowledge.