QA Compliance Specialist

Abbott; Olst-Wijhe; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

13th month bonus

Sport allowance

Personal development budget

Job summary

Abbott is seeking a QA Specialist A to join the Quality Assurance team in Olst. You will help ensure our products meet high quality standards and comply with GMP and internal requirements, collaborating across regulatory affairs, production, QC, and operations.

You will assess regulatory dossiers, handle deviations and quality issues, participate in audits, and review quality documents, contributing to product quality and patient safety. A strong emphasis on ownership and teamwork is expected.

Qualifications

• Bachelor’s degree in a relevant field (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

Responsibilities

• Ensure Abbott products are and remain compliant with regulatory dossiers
• Assess regulatory product dossiers and implement changes within the local organization
• Act as 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

Skills

QA/regulatory awareness

Regulatory compliance

Documentation

MS Office

Education

Bachelor’s degree in science/pharmacy/engineering

Tools

MS Office

Job description

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.