Quality Auditor - Established Pharmaceuticals Division

Abbott; Weesp; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Abbott in Weesp, Netherlands, is seeking a Quality Auditor to oversee supplier and third-party manufacturer audits within the Established Pharmaceuticals Division (EPD). You will manage on-site audits, CAPAs, and quality questionnaires to ensure regulatory adherence and patient safety.

The role requires 8+ years in pharma/regulatory environments, including 3+ years auditing, and strong knowledge of ICH, GMP, and WHO guidelines. Travel internationally as needed.

Qualifikationen

• Bachelor's degree in a relevant science or engineering field.
• At least 8 years in pharma/healthcare/regulatory with 3+ years auditing experience (GMP, GDP, ISO).
• Strong knowledge of ICH GMP WHO and local regs.
• Experience auditing suppliers/3rd party manufacturers across pharma or medical devices.
• Excellent written and verbal Business English.

Aufgaben

• Plan, prepare, conduct, report, and close on-site audits for suppliers and third-party manufacturers.
• Manage Quality Questionnaires for suppliers and third-party manufacturers and resolve issues.
• Track CAPAs to ensure timely and effective closure.
• Document audit outcomes in the Audit Tracking system.
• Provide timely audit updates to management and stakeholders and escalate critical findings.
• Monitor regulatory developments and integrate into audit activities.
• Support Abbott manufacturing sites in resolving supplier-related quality issues.
• Act as the primary quality contact for external partners on auditing matters.

Kenntnisse

Auditing

Quality systems

Regulatory knowledge

Communication skills

Ausbildung

Bachelor's degree in a scientific/technical field

Tools

Audit Tracking System

Jobbeschreibung

Within Abbott's Established Pharmaceuticals Division (EPD), we provide high-quality, trusted medicines that improve access to healthcare around the world.

The Opportunity
Abbott is seeking a Quality Auditor to support supplier and third-party manufacturer oversight for EPD. Based in Weesp, this role plays a critical part in ensuring compliance, quality, and regulatory adherence across Abbott's external partner network.

You will manage on-site audits and quality assessments for a broad range of suppliers and third-party manufacturers, working closely with internal stakeholders and external partners to drive continuous improvement and ensure patient safety.

What You'll Do

• Plan, prepare, conduct, report, and close on-site audits for suppliers and third-party manufacturers supporting EPD.
• Manage Quality Questionnaires for suppliers and third-party manufacturers and resolve any identified issues.
• Assess, track, and follow up on Corrective and Preventive Actions (CAPAs) to ensure timely and effective closure.
• Ensure all audit activities and outcomes are accurately documented in the Audit Tracking system.
• Provide timely audit updates to management and stakeholders, escalating critical findings in line with policies and procedures.
• Monitor regulatory developments, standards, and industry trends and integrate them into audit activities.
• Support EPD manufacturing sites in resolving supplier-related quality and compliance issues.
• Act as the primary quality contact for external partners on auditing matters and promote a proactive quality mindset.

What You'll Bring

• Bachelor's degree in a relevant scientific or technical discipline (e.g. Chemistry, Pharmacy, Biology, Microbiology, Engineering) or equivalent industry experience.
• At least 8 years’ experience in the pharmaceutical, healthcare, or regulatory environment, including a minimum of 3 years of auditing experience (GMP, GDP, ISO).
• Strong knowledge of ICH guidelines, GMP standards, WHO guidance, and applicable regional and local regulations.
• Proven experience auditing suppliers and/or third-party manufacturers across pharmaceutical, medical device, or nutrition product types.
• Strong analytical skills with the ability to identify compliance risks and drive effective corrective actions.
• Excellent communication skills with advanced written and verbal Business English.
• High level of integrity, independence, adaptability, and cultural awareness, with willingness and ability to travel internationally.

Working at Abbott

At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You will have access to career development opportunities within an international company recognized as a great place to work in multiple countries. Abbott has been named one of the most admired companies in the world by Fortune and is recognized for its commitment to diversity, inclusion, and innovation.

We are an equal opportunity employer and value diversity in our workforce. We welcome applications from all qualified individuals regardless of gender, age, ethnicity, religion, disability, sexual orientation, or any other characteristic protected by law.