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Quality Engineer Leiden • Panda International
Gevraagd
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Fulltime
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HBO of hoger
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Ervaren/Expert
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Engels (taal)
Aanbod
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Loondienst (vast)
Vacature in het kort
Leiden
Become a part of an innovative team in the life sciences sector, contributing as a Quality Operations Specialist. You'll engage in both routine and complex quality tasks, managing CAPA investigations, change controls, and collaborating with diverse teams to maintain compliance with GMP standards. This role invites you to shape product quality and operational excellence while driving quality improvement projects and audits in a fast-paced environment, offering a great opportunity for professional growth. See how this role can help you achieve your professional goals.
Over het bedrijf
Panda International
Volledige vacaturetekst
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:
Send your CV to via de button "Solliciteer nu" op deze pagina.
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
- 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)
- 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
- Location: Leiden
- Contract Type: Full-time
- Start Date: ASAP
- Language Requirements: English required
Send your CV to via de button "Solliciteer nu" op deze pagina.
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
- 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)
- 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
- Location: Leiden
- Contract Type: Full-time
- Start Date: ASAP
- Language Requirements: English required
Send your CV to via de button "Solliciteer nu" op deze pagina.
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