Qualified Person / QP (f/m/d)

STADA Arzneimittel AG; Bad Vilbel; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Ein führendes pharmazeutisches Unternehmen in Bad Vilbel sucht einen Qualified Person (m/w/d) zur Überwachung der Qualitätskontrolle. Sie prüfen und genehmigen Produkte, stellen die Einhaltung von Vorschriften sicher und unterstützen bei der Dokumentation. Idealerweise haben Sie einen Abschluss in Pharmazie oder Naturwissenschaften und sprechen fließend Deutsch und Englisch. Wir bieten flexible Arbeitszeiten und zahlreiche zusätzliche Leistungen.

Leistungen

Flexibles Arbeiten

Individuelle Entwicklungs- und Weiterbildungsmöglichkeiten

Gesundheitsfördernde Angebote

Qualifikationen

• Abgeschlossenes Studium in Pharmazie mit Zulassung oder in Naturwissenschaften.
• Gute Kenntnisse der rechtlichen Rahmenbedingungen wie cGMP, AMG und AMWHV.
• Fähigkeit zur Kommunikation in Deutsch und Englisch.

Aufgaben

• Gewährleistung der Einhaltung rechtlicher Vorschriften bei der Herstellung und Prüfung.
• Genehmigung oder Ablehnung von Roh- und Fertigprodukten.
• Überwachung der Umsetzung von Tests im Einklang mit den GMP-Richtlinien.

Kenntnisse

Pharmazeutische Analytik

Initiative

Durchsetzungsvermögen

Kommunikationsfähigkeit

Deutsch (fließend)

Englisch (fließend)

Ausbildung

Abschluss in Pharmazie oder Naturwissenschaften

Jobbeschreibung

Overview

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"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Qualified Person / QP (f/m/d)

Bad Vilbel | Germany (DE) | Full-time | Permanent | Quality | Professionals

What you can expect

As a Qualified Person in Finished Product Control, you take on the critical responsibility as a Qualified Person according to §14 AMG and as the Head of Quality Control according to §14 AMWHV for products not manufactured and packaged at the Bad Vilbel site.

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them
• You determine the required scope of testing and monitor implementation, considering legal frameworks, GMP guidelines, and cost-effectiveness
• You address issues arising from daily operations
• You ensure the implementation of QS-relevant parts of CCPs/MOCs
• You handle deviations and test reports as well as OOS-specific issues
• You organize departmental documentation in accordance with GMP guidelines
• You evaluate PQRs (Product Quality Reviews) and stability studies

Who we are looking for

• You have completed a degree in pharmacy with licensure or a degree in natural sciences
• You possess the qualification according to the expert opinion under §15 AMG
• You have good knowledge of legal frameworks such as cGMP, AMG, and AMWHV
• You are skilled in the field of pharmaceutical analytics
• You demonstrate initiative and have assertiveness
• You communicate effectively and clearly
• You are proficient in both spoken and written English and German

What we offer

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development
• Individual development and training opportunities
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
• Job ticket for the RMV region and Job Bike
• Childcare allowance
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
• Numerous additional benefits such as group accident insurance or supplementary pension scheme

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to [e-mail]. We will consider requests to work part-time on an individual basis. Please contact us in advance by e-mail ([e-mail]) and let us know how many hours per week you would like to work.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment. #LI-DH1