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Qualified Person (m/w/d)

Req #: JR - 050997 Location Halle, North Rhine-Westphalia, Germany Job Category: Quality Control Date Posted: 10/12/2021

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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Qualified Person (m/w/d)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Was unser Team auf der ganzen Welt verbindet, ist das tägliche Engagement, um Leben zu retten und zu erhalten.

Wir produzieren in unserem Werk in Halle/Westfalen Arzneimittel zur Therapie verschiedener Krebs- und anderer lebensbedrohenden Erkrankungen. Neben eigenen Produkten sind dies Medikamente, die wir in Lohnherstellung für Dritte produzieren. Die Baxter Oncology ist bei vielen dieser lebensrettenden Medikamente der weltweit einzige Hersteller.

Qualified Person (m/w/d)

Aufgaben:

Als Qualified Person (Sachkundige Person gem. Richtlinie 2001/83/EG Artikel 49 und Arzneimittelgesetz §15) sind Sie für die Chargenzertifizierung und –freigabe der am Standort hergestellten Arzneimittel verantwortlich. Sie stellen sicher, dass jede einzelne Charge eines Arzneimittels in Übereinstimmung mit den gesetzlichen Vorgaben und Zulassungsunterlagen hergestellt und geprüft wurde. Dieses beinhaltet im Einzelnen:

  • Chargenfreigabe von Bulkware und Fertigprodukten
  • Bewertung von Abweichungen in Bezug auf die Qualität des Produkts
  • Bewertung von Produktbeschwerden gemäß den gesetzlichen Bestimmungen
  • Bewertung von produktspezifischen Qualitätsberichten (APQR)
  • Technische und analytische Unterstützung der Produktion / Qualitätskontrolle
  • Freigabe von Quality Agreements
  • KPI Management, z. B. Liefertermintreue
  • Erarbeitung von Spezifikationen und Methoden für die Packmittelprüfung/ Endkontrolle
  • Fachliche Betreuung der Endkontrolle, Probenziehung, Prüfung der Sekundärpackmittel

Anforderungen:

  • Erfolgreich abgeschlossenes Studium zum Apotheker (m/w/d)
  • Qualifikation als Sachkundige Person / Qualified Person nach §15 AMG
  • Mehrjährige Erfahrung in der Pharmaindustrie
  • Erfahrung in der aseptischen Herstellung
  • Nachgewiesene Kenntnis der EG-GMP-Richtlinien und ihrer Auslegung, insbesondere der Anhänge 1 und 16
  • Freude an der aktiven Übernahme von Verantwortung
  • Fähigkeit, Ziele erfolgreich zu erreichen und sowohl klar als auch offen zu kommunizieren
  • Verhandlungssicheres Deutsch und Englisch

Was wir bieten:

Baxter bietet anspruchsvolle Herausforderungen mit Entwicklungspotential. Bei uns treffen Sie auf eine integrative und vielfältige Unternehmenskultur, die Unterschiede fördert und Ihnen die Möglichkeit bietet, sich mit Kolleginnen und Kollegen auf der ganzen Welt zu vernetzen.

Mehr zu unseren Karrieremöglichkeiten finden Sie unter:

https://jobs.baxter.com/

Wer wir sind:

Unsere Produkte und Therapien werden täglich von Millionen Menschen weltweit, sowohl in Kliniken als auch bei Patienten zu Hause, angewendet. Dabei vertrauen Patienten und Ärzte auf unsere lebensrettenden Produkte aus den Bereichen Nierenersatztherapie, Anästhesie, Chirurgie, Infusionstherapie, künstliche Ernährung, Onkologie und Schmerztherapie. Baxters Mission Leben zu retten und zu erhalten motiviert weltweit rund 50.000 Mitarbeitende in über 100 Ländern.

Engagierten und begabten Menschen bieten wir interessante Chancen. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Beeinträchtigungen spielen dabei keine Rolle - im Gegenteil: Wir fördern Vielfalt und glauben, dass Diversität eine Bereicherung darstellt: https://www.charta-der-vielfalt.de/

#IND-DACH

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

050997

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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