Manager (m/f/d) Qualification/ Validation

Eckert & Ziegler Strahlen- und Medizintechnik AG; Berlin; Vor Ort; EUR 60.000 - 85.000; Teilzeit

Benefits dieser Stelle

Mobile working

Flexible hours

30 vacation days

JobTicket

Ergonomischer Arbeitsplatz

Zusammenfassung

Eckert & Ziegler Radiopharma GmbH sucht eine Fachkraft für Qualifikation und Validierung in einem pharmazeutischen Umfeld.

Sie arbeiten in einer 30-Stunden-Woche, mit Schwerpunkt auf GMP-Dokumentation, Qualifikationen und Validierungen sowie dem Lifecycle-Management von Anlagen. Erfahrungen im Reinraum und gute Deutsch-/Englischkenntnisse (mind. B2) sind erforderlich.

Qualifikationen

• Abgeschlossenes technisches oder Naturwissenschaftliches Studium bzw. vergleichbare Ausbildung.
• Berufserfahrung in Qualification/Validation in der Pharmaindustrie.
• Gute praktische GMP-Kenntnisse.
• Bereitschaft zur Arbeit im Reinraum.
• Zuverlässigkeit, Selbstständigkeit & gute Kommunikationsfähigkeit.
• Sehr gute Deutsch- und Englischkenntnisse (mind. B2).

Aufgaben

• Strategische Planung, Organisation und Durchführung von Wartung, Kalibrierung, Qualifikation und Validierung.
• GMP-konforme Dokumentation der genannten Tätigkeiten.
• Erstellung, Prüfung und Freigabe von Qualifikations- und Validierungsdokumenten einschließlich Risikobewertungen.
• Aufbau und Pflege des Lifecycle-Managements von Anlagen und Systemen.
• Unterstützung des QP bei der Prüfung des Qualifikationsstatus von Anlagen, Einrichtungen und Validierung.
• Umsetzung von Gesetzen, Verordnungen und Richtlinien im Rahmen von Qualifikation und Validierung.
• Sicherstellung vollständiger Dokumentation, Untersuchung und Behebung von Problemen.

Kenntnisse

GMP Kenntnisse

Deutsch (B2)

Englisch (B2)

Reinraum-Arbeit

Zuverlässigkeit

Selbstständigkeit

Kommunikationsfähigkeit

Qualifikation & Validierungserfahrung

Ausbildung

Abgeschlossenes technisches oder Naturwissenschaftliches Studium bzw. vergleichbare Ausbildung

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.

This position is for a 30-hour workweek and is not suitable for working students.

Your contribution to success

• Strategic planning, organization, and execution of maintenance, calibrations, and qualification and validation activities
• GMP-compliant documentation of the aforementioned activities
• Preparation, review, and approval of qualification and validation documents, including risk assessments
• Establishment and maintenance of the lifecycle management of equipment and systems
• Supporting the QP in reviewing the qualification status of equipment and facilities, as well as the validated status of processes, analytical methods, and computer applications
• Implementing laws, regulations, and guidelines within the scope of qualification and validation
• Ensuring comprehensive documentation, investigation, and resolution of issues

This qualifies you

• A successfully completed degree in a technical or natural science field or completion of comparable vocational training
• Professional experience in the field of qualification and validation at a pharmaceutical company
• Good practical knowledge of GMP guidelines
• Willingness to work in a cleanroom and in a controlled area
• High level of reliability and independence, as well as strong communication skills
• Very good written and spoken German and English skills (minimum B2 level)

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 CampusVital Card, 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

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.