QA Compliance Specialist

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 Dutch and English.

• 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.

Interested?

Apply directly with your CV!

Recruitment is conducted on an ongoing basis, and the process will close once the right candidate has been identified. If you meet the qualifications and are interested in this opportunity, we encourage you to apply as soon as possible.

The base pay for this position is

N/AIn specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Netherlands > Olst : OAD

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable