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Quality Engineer

LocationLeiden, Netherlands
Business SectorPharmaceutical
Contact email
Job ref25920
Publishedabout 1 hour ago
Quality Operations Specialist – Operations & Compliance
Leiden – Full-time
Company Description
We are collaborating with a leading organization in the life sciences sector, committed to advancing high-quality production processes and ensuring regulatory compliance across operations. Their team plays a critical role in maintaining quality standards, supporting continuous improvement initiatives, and safeguarding product excellence.
 
Job Description
As a Quality Operations Specialist, you will be a key contributor to the Operations team, executing both routine and non-routine quality tasks. You will manage CAPA investigations, change controls, and quality documentation while collaborating with cross-functional teams to ensure compliance with GMP standards. Reporting to the Operations Manager, you will actively participate in audits, risk mitigation initiatives, and quality improvement projects. This role offers a unique opportunity to influence operational excellence and product quality in a dynamic, fast-paced environment.
Key Responsibilities:
  • Execute nonconformance investigations, including CAPA records and lead change controls from initiation through completion
  • Review and maintain procedures, protocols, and documentation according to regulatory requirements
  • Perform GEMBA walks to observe adherence to GMP standards and identify areas for improvement
  • Initiate and implement risk mitigation and continuous quality improvement projects
  • Support audits, inspections, and training program development for GMP processes
  • Analyze recurring quality issues and recommend corrective actions
  • Ensure compliant and timely completion of all quality records
  • Escalate issues and risks to maintain visibility for stakeholders
Essential Requirements:
  • BSc/HBO in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
  • 3+ years’ experience in Quality Operations, Quality Assurance, or a related role
  • Hands-on experience with CAPA, change controls, and quality investigations
  • Knowledge of GMP standards and operational compliance
  • Strong analytical skills and attention to detail with ability to identify root causes and implement solutions
  • Excellent written and verbal communication skills
  • Proactive, organized, flexible, and able to work independently or in a team
  • Fluent in English (both written and spoken)
Desirable Experience:
  • Experience supporting audits and inspections in a regulated environment
  • Involvement in continuous quality improvement initiatives
  • Previous work in the pharmaceutical, biotech, or life sciences industry
Additional Insights:
  • Location: Leiden
  • Contract Type: Full-time
  • Start Date: ASAP
  • Language Requirements: English required
Interested?
Send your CV to f.chauca@panda-int.com
Quality Operations Specialist – Operations & Compliance
Leiden – Full-time
Company Description
We are collaborating with a leading organization in the life sciences sector, committed to advancing high-quality production processes and ensuring regulatory compliance across operations. Their team plays a critical role in maintaining quality standards, supporting continuous improvement initiatives, and safeguarding product excellence.
 
Job Description
As a Quality Operations Specialist, you will be a key contributor to the Operations team, executing both routine and non-routine quality tasks. You will manage CAPA investigations, change controls, and quality documentation while collaborating with cross-functional teams to ensure compliance with GMP standards. Reporting to the Operations Manager, you will actively participate in audits, risk mitigation initiatives, and quality improvement projects. This role offers a unique opportunity to influence operational excellence and product quality in a dynamic, fast-paced environment.
Key Responsibilities:
  • Execute nonconformance investigations, including CAPA records and lead change controls from initiation through completion
  • Review and maintain procedures, protocols, and documentation according to regulatory requirements
  • Perform GEMBA walks to observe adherence to GMP standards and identify areas for improvement
  • Initiate and implement risk mitigation and continuous quality improvement projects
  • Support audits, inspections, and training program development for GMP processes
  • Analyze recurring quality issues and recommend corrective actions
  • Ensure compliant and timely completion of all quality records
  • Escalate issues and risks to maintain visibility for stakeholders
Essential Requirements:
  • BSc/HBO in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field
  • 3+ years’ experience in Quality Operations, Quality Assurance, or a related role
  • Hands-on experience with CAPA, change controls, and quality investigations
  • Knowledge of GMP standards and operational compliance
  • Strong analytical skills and attention to detail with ability to identify root causes and implement solutions
  • Excellent written and verbal communication skills
  • Proactive, organized, flexible, and able to work independently or in a team
  • Fluent in English (both written and spoken)
Desirable Experience:
  • Experience supporting audits and inspections in a regulated environment
  • Involvement in continuous quality improvement initiatives
  • Previous work in the pharmaceutical, biotech, or life sciences industry
Additional Insights:
  • Location: Leiden
  • Contract Type: Full-time
  • Start Date: ASAP
  • Language Requirements: English required
Interested?
Send your CV to f.chauca@panda-int.com