QA Compliance Specialist

Abbott Laboratories; Netherlands; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

13th month

Sport allowance

Personal development budget

Job summary

Abbott Laboratories in Olst, Netherlands, is seeking a QA Specialist A to join the Quality Assurance team. You will ensure products meet GMP and internal quality standards, and you will work with diverse teams to maintain product quality and patient safety.

You will assess regulatory dossiers, implement changes locally, and serve as QA/regulatory representative on projects. You’ll investigate deviations, support audits, and review GxP/QMS documents while driving continuous improvement across

Qualifications

• Bachelor’s degree in a relevant field; 5+ years in a pharmaceutical or highly regulated environment.
• Excellent understanding of GMP and regulatory processes.
• Good English communication; Dutch optional.

Responsibilities

• Ensure regulatory dossiers compliance and oversee regulatory product documentation.
• Act as regulatory compliance representative in projects and changes.
• Handle deviations, complaints and quality issues; investigate and resolve.
• Support audits and inspections and review quality documents (GxP/QMS).
• Collaborate with regulatory affairs, production, QC and operations.

Skills

English communication

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in a relevant field

Tools

MS Office

Job description

Descritivo de Cargo

We are looking for a QA Specialist A to join our Quality Assurance team in Olst!. In this role of regulatory compliance specialist, you will help ensure that our products meet high quality standards and comply with GMP and internal requirements. You will work closely with different teams across the organization and play an important role in maintaining product quality and patient safety.

What will you do?

Ensure that Abbott products are and remain compliant with regulatory dossiers. Assess regulatory product dossiers and take the initiative to implement any necessary changes within the local organization. Act as a QA (regulatory compliance) representative in projects and changes. Handle and investigate deviations, complaints and quality issues. Support and participate in audits and inspections. Review and approve quality documents (GxP / QMS). Support continuous improvement activities. Work with stakeholders across regulatory affairs, production, QC, and operations.

Who are you?

You are a structured and quality-focused person who enjoys working in a collaborative environment. You take ownership of your work and are comfortable handling tasks independently, while also working closely with others. You are curious and motivated to understand processes and improve them. You are not afraid to ask questions and speak up when something doesn’t look right. You would likely describe yourself as: Detail-oriented, with a strong focus on quality and regulatory compliance. Good at organizing your work and managing priorities. A team player who communicates clearly and builds good relationships. Comfortable working with different stakeholders across the organization. Initiative-taking, proactive, and solution-oriented. Open to learning and developing skills. Familiar with the dynamics of a manufacturing and quality environment.

Your background Bachelor’s degree in a relevant field (e.g. science, pharmacy, engineering). Minimum of 5 years of experience in a pharmaceutical or other highly regulated environment. Understanding of GMP, quality, and regulatory processes. Good communication skills in English, Dutch is optional. Excellent MS Office skills.

What we offer

A supportive and collaborative team environment. Opportunities to learn and develop within QA. The opportunity to make a real impact on product quality and patient safety. Competitive compensation and benefits including a 13th month, a sport allowance, and a personal development budget.

The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.

Mandatory Information & Conditions

Operations Quality Divisão EPD

Established Pharma

Localidade Netherlands > Olst : OAD

Localidades Adicionais

Turno de Trabalho Standard

Viagem Not specified

Vigilância médica Not Applicable

Atividades de trabalho significativas Not Applicable

Company Mandate

A Abbott significa o poder da saúde. Por mais de 125 anos, a Abbott tem ajudado as pessoas a alcançar seu potencial — porque uma saúde melhor permite que indivíduos e comunidades vivam melhor. Com uma rede global e diversificada, que serve clientes em mais de 160 países, criamos novas soluções — em todo o espectro da saúde, em todo o mundo, para todas as fases da vida. Seja através da próxima geração de equipamentos de diagnóstico, dispositivos médicos para estilos de vida em transformação, nutrição baseada em ciência, ou novas reformulações, estamos desenvolvendo tecnologias mais inovadoras e revolucionárias na área da saúde para que indivíduos vivam melhor e com mais saúde. Os colaboradores da Abbott vêm trabalhar todos os dias com energia, entusiasmo e comprometimento com o intuito de promover a saúde e o bem-estar de milhões de pessoas. Eles superam os limites para ajudar a gerenciar e tratar alguns dos maiores desafios de saúde da vida.

Convidamos você a explorar as oportunidades na Abbott, a ver se seus talentos e aspirações de carreira podem se encaixar com as nossas vagas. A Abbott é uma empresa que oferece oportunidades iguais e acolhe e incentiva a diversidade em nossa força de trabalho.

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