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QA Compliance Specialist

Abbott

Olst
Full-time
5-10 years experience
On-site

Key Skills

Regulatory compliance
GMP
Quality assurance
Deviation management
Complaint handling
Audit support
Document review
GxP
QMS
Regulatory affairs
Quality control
Process improvement
Stakeholder management
MS Office

Job Description

     

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/A

In 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

     

     

     

Core Responsibilities

The QA Compliance Specialist will ensure product compliance with regulatory dossiers and GMP standards while managing deviations and quality issues. They will also act as a QA representative in projects and collaborate with cross-functional teams to support continuous improvement.

Requirements

Candidates must hold a bachelor's degree in a relevant field such as science, pharmacy, or engineering. A minimum of 5 years of experience in a pharmaceutical or highly regulated environment is required, along with proficiency in Dutch and English.

Benefits

  • 13th month
  • Sport allowance
  • Personal development budget

About Abbott

Industry: Hospitals and Health Care

Company size: 10,001+ employees

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Terms of Use: https://www.abbott.com/social-media-terms-of-use.html Privacy Policy: https://abbo.tt/privacy

Added 1 months ago