Quality Assurance Employee (m/f/d) for Batch Record Review

Eckert & Ziegler Strahlen- und Medizintechnik AG; Berlin; Vor Ort; EUR 40.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der Radiopharmaindustrie sucht nach engagierten Talenten, die dazu beitragen, Leben zu retten. In dieser Rolle sind Sie verantwortlich für die Überprüfung von Chargendokumentationen und die Schulung von Mitarbeitern, um sicherzustellen, dass alle Prozesse den höchsten Qualitätsstandards entsprechen. Sie werden Teil eines dynamischen Teams, das innovative Lösungen entwickelt und dabei hilft, neue therapeutische Möglichkeiten in der Krebsbehandlung zu schaffen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem unterstützenden Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Flexible Arbeitszeiten

30 bezahlte Urlaubstage

Betriebliche Gesundheitsförderung

JobTicket

Ergonomische Arbeitsplätze

Familienfreundliche Regelungen

Qualifikationen

• Erfahrung im Qualitätsmanagement in einem GMP-Umfeld ist wünschenswert.
• Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift erforderlich.

Aufgaben

• Überprüfung der Chargendokumentation gemäß den geltenden SOPs.
• Schulung der Mitarbeiter in der korrekten Erstellung von Chargendokumenten.

Kenntnisse

Dokumentenmanagement

Teamarbeit

Zuverlässigkeit

Initiative

Ausbildung

Abschluss in Naturwissenschaften

Tools

MS Office

Jobbeschreibung

CONTRIBUTING TO SAVING LIVES | WIR HELFEN ZU HEILEN

Eckert & Ziegler Radiopharma GmbH, a subsidiary of the renowned and internationally active Eckert & Ziegler Group, has been an important and reliable partner to the radiopharmaceutical industry for over 20 years.

Radiopharmaceuticals have become an indispensable part of modern medicine. They play a particularly important role in the research and development of new therapeutic options, but also in the treatment and diagnosis of various types of cancer. We supply clinics, pharmaceutical companies and institutes with GMP-compliant radioisotopes and radiopharmaceuticals and develop tailor-made solutions for research companies. With our support, new processes and methods are created from development to production.

Join our ambitious and highly skilled team and help to heal.

Your contribution to success

• Review of batch documentation (batch records) in accordance with the applicable SOPs and coordination of any necessary corrections by production and/or quality control
• Conducting and compiling the formal batch record review in preparation for release by the qualified person
• Training employees in the correct way to complete batch documentation and how to review it
• Involvement in self-inspections and inspections by the authorities, as well as external audits
• Creation of product quality reviews
• Implementation of laws, regulations and guidelines in the quality assurance system

This qualifies you

• Degree in natural sciences or comparable qualification
• Experience in quality management/assurance in a GMP environment is desirable
• An affinity for reviewing and managing documents
• Good knowledge of the common MS Office applications
• Very good German (at least C1 level) and English (at least B2 level) language skills, both written and spoken
• Ability to work in a team, commitment and initiative
• Reliability, resilience and a strong sense of accuracy

You can look forward to

• Flexibility: working arrangements such as mobile working, flexible working hours and paid leave for specific reasons (e.g. moving house, cancer check-ups) to help you achieve the best work-life balance
• Family friendly: Helping you balance family and career by offering paid time off for family events, such as sick days for children, parental start time or your own wedding.
• Compensation package: Attractive compensation, plus savings plans and vouchers for benefits in kind or the JobTicket
• Annual leave and time off: 30 paid vacation days for regular rest and recuperation
• Workplace comfort: pleasant working environment with no open-plan offices or shift work, and ergonomic desks and chairs for comfort at work
• Stability & Prospects: A secure job in an established company with long-term prospects and development opportunities.
• Health promotion: company health management with health days and initiatives such as "Fit and active in the day" - the health of our employees is important to us
• Mobility diversity: JobTicket, e-bike leasing, good public transport links, as well as company charging points for electric cars and the opportunity to recharge e-bike batteries free of charge for sustainable mobility

We look forward to receiving your application!

Please apply by using our online application form, which can be easily accessed by clicking on the "Apply Now" button at the end of each vacancy.

In our search for new talent, we welcome all applications regardless of gender, age, race, sexual identity, disability, religion or belief. We value diversity and the different perspectives you can bring to our business. We welcome your application even if you do not meet all of the criteria, because we value individual skills, motivation and potential over categorisation.

Show us what makes you special. Take the next step in your career and send us your informative application documents, stating your salary expectations and your earliest possible starting date.