Qualified Person (QP)

H.Essers; Frankfurt; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

In dieser spannenden Rolle als Qualified Person in einem innovativen Unternehmen erwartet Sie die Verantwortung für die Qualität und Sicherheit von pharmazeutischen Produkten. Sie werden Teil eines dynamischen Teams, das sich für kontinuierliche Verbesserung und Einhaltung von Vorschriften einsetzt. Ihre Expertise wird geschätzt, während Sie mit internen und externen Stakeholdern zusammenarbeiten, um höchste Qualitätsstandards zu gewährleisten. Profitieren Sie von einem unterstützenden Arbeitsumfeld, das persönliches Wachstum fördert und Ihre Gesundheit priorisiert. Wenn Sie eine Leidenschaft für Qualität und Logistik haben, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Lifelong Learning durch H.Essers Academy

Fit2Grow Gesundheitsprogramm

Dynamisches Arbeitsumfeld

Familienwerte und Job-Sicherheit

Qualifikationen

• Mindestens fünf Jahre Erfahrung als Qualified Person.
• Kenntnisse in der Verwaltung von Qualitätssystemen für pharmazeutische Produkte.

Aufgaben

• Sicherstellung der Einhaltung von EU-GMP-Vorschriften.
• Überwachung der Qualitätssicherungsprozesse und Durchführung von Risikoanalysen.

Kenntnisse

Qualitätsmanagement

Analytische Fähigkeiten

Problemlösungsfähigkeiten

Kenntnisse der GMP-Vorschriften

Fließend in Englisch und Deutsch

Ausbildung

Universitätsabschluss in Pharmazie

Abschluss in Chemie oder Biologie

Jobbeschreibung

Are you ready to combine your passion for quality and logistics in the dynamic role of Qualified Person? Discover the challenges and rewards that come with this role at H.Essers, Frankfurt area.

YOUR CHALLENGES

As a QP, you play a crucial role in ensuring the quality and safety of pharmaceutical products. You are responsible for the continuous improvement of the quality systems for pharmaceutical products within H.Essers and act as a contact point for government agencies to guarantee good quality for our customers.

What this means specifically :

1. Ensure compliance with EU GMP regulations and other relevant standards.
2. Oversee the quality processes for a site with a MIA for physical importation.
3. Manage quality assurance processes, including validation, deviation management, change control, external supplier management, and customer qualification.
4. Conduct risk assessments and implement corrective and preventive actions.
5. Collaborate with cross-functional teams to maintain and improve quality systems.
6. Provide expert guidance on quality-related matters to internal and external stakeholders.
7. Participate in regulatory inspections and audits, ensuring all licenses are acquired and findings addressed promptly and effectively.

YOUR TALENTS

1. You hold a university degree in pharmacy, medicine, chemistry, biology, or a related scientific discipline.
2. You have at least five years of experience as a QP.
3. Thorough knowledge of GMP and relevant regulations is essential.
4. You possess strong analytical and problem-solving skills.
5. The ability to work independently and make decisions is crucial.
6. Experience with importation processes and managing distribution sites with MIA for physical importation is an asset.
7. Experience working with the Bundesinstitut für Arzneimittel und Medizinprodukte for license requests is a plus.
8. You communicate fluently in both English and German.

YOUR REWARD

1. Your salary is competitive and complemented by attractive benefits.
2. Enjoy a dynamic and stimulating work environment where you can make a significant contribution.
3. Benefit from our 'Lifelong Learning' vision through the H.Essers Academy, offering various training courses for your personal development.
4. Your physical and mental health are supported through H.Essers' Fit2Grow health program.
5. Become part of the strong H.Essers family, your greatest asset.

7500 REASONS TO CHOOSE H.ESSERS

1. Family values: a foundation of trust and commitment since 1928.
2. Job security in a rapidly changing world.
3. Ambitious team of 7500 colleagues striving for excellence.
4. Innovation in processes and services for better customer service.
5. Sustainable international growth with social, economic, and environmental responsibility.
6. Diversity and inclusion are actively embraced.

These are just a few reasons why H.Essers is an attractive choice. We look forward to discovering your reasons.