Quality Auditor, Weesp
Quality Auditor, Weesp
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1380 Weesp, Nederland
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Gewijzigd op: minder dan een week geleden
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Onthouden
Advertentietekst
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.
Fluency in Dutch is required, with the ability to communicate professionally with local stakeholders in the Netherlands.
High level of integrity, independence, adaptability, and cultural awareness, with willingness and ability to travel internationally.
Equal Opportunity 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.
#J-18808-Ljbffr
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.
Fluency in Dutch is required, with the ability to communicate professionally with local stakeholders in the Netherlands.
High level of integrity, independence, adaptability, and cultural awareness, with willingness and ability to travel internationally.
Equal Opportunity 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.
#J-18808-Ljbffr
Belangrijke informatie
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BedrijfsnaamAbbott Laboratories
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PositieQuality Auditor
Veiligheidstips
Bescherm je prive gegevens en communiceer via ons contactformulier.
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