Quality Assurance Specialist

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

Quality Assurance Specialist – GMP Biologics

Location: Netherlands

Working model: Hybrid – 2 days per week on site

Experience: Approximately 4–5 years within pharmaceutical/biopharmaceutical Quality Assurance

Role Overview

We are looking for a Quality Assurance Specialist to join a GMP-regulated biologics environment in the Netherlands. The role will provide hands‑on QA support across manufacturing and quality systems, with particular responsibility for deviations, investigations, CAPA and ongoing GMP compliance.

The ideal candidate will have experience working within a pharmaceutical or biopharmaceutical manufacturing environment and be comfortable partnering with Manufacturing, QC, Engineering and other technical functions to identify, investigate and resolve quality issues.

Experience across upstream and/or downstream biologics manufacturing, particularly monoclonal antibody (mAb) processes, would be a strong advantage.

Key Responsibilities

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

Technical Environment

The successful candidate will ideally have experience with:

• GMP / GxP-regulated pharmaceutical or biotechnology manufacturing
• Deviation and investigation management
• CAPA and root-cause analysis
• Change control
• QMS processes and documentation
• TrackWise or a comparable electronic QMS
• Batch record/document review
• Risk management and quality impact assessments
• Audit and inspection support
• Good Documentation Practices and data integrity
• Manufacturing quality oversight

Biologics Experience – Advantage

Experience within biologics manufacturing is highly desirable, particularly exposure to monoclonal antibody processes.

Knowledge of either or both:

• Upstream: cell culture, media/feed preparation, bioreactors, inoculation, harvest and related manufacturing activities.
• Downstream: clarification, chromatography, filtration, purification, UF/DF and related purification processes.

Candidates do not necessarily need to be experts in both areas, but exposure to biologics manufacturing and an understanding of how quality issues can impact the overall manufacturing process would be valuable.

Candidate Profile

• 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.