QA-Delegate (jeglichen Geschlechts) - #933567

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

• Durchführung täglicher Kontrollgänge zur Überprüfung der Einhaltung von GMP in der Produktion und produktionsnahen Bereichen
• Unterstützung bei Selbstinspektionen der Produktion sowie der Qualitätssicherung
• Kontrolle der Einhaltung der GMP - Vorgaben bei der Dokumentation
• Selbständige Koordination und Planung der Kontrolle und Durchführung von Media Fills innerhalb der MF1
• Unterstützung der Entscheidungen bei schwerwiegenden Abweichungen wie z.B. Chargentrennung, neues Set Up einer Linie, Vernichtung von Teilchargen etc.
• Erkennung und Veranlassung der Abstellung von Abweichungen insbesondere im Hygieneverhalten der Mitarbeiter
• Auswertung von Abweichungstrends zusammen mit der Produktion und Veranlassung der Durchführung der erforderlichen Aktivitäten
• Kontrolle der Abarbeitung von festgelegten Maßnahmen aus Audits, Maßnahmenplänen, Abweichungen und Reklamationen sowie Überwachung der Termine
• Veranlassung von notwendigen Produktionsstopps in Abstimmung mit dem Leiter der Herstellung bzw. dem Schichtleiter im Falle von schwerwiegenden Abweichungen im Produktionsbereich bzw. im produktionsnahen Bereich
  
  
  

Your profile

• Abgeschlossenes naturwissenschaftliches Studium der Chemie, Biologie, Life Science, Pharmatechnik oder vergleichbar
• Möglichst 2-4 Jahre Berufserfahrung in der Pharmaproduktion, vorzugsweise sterile Arzneiformen
• Sprachkenntnisse (Deutsch und Englisch in Wort und Schrift)
• Entscheidungskompetenz im Rahmen des Aufgabengebietes
• Konfliktfähigkeit, Teamfähigkeit mit ausgeprägter Fähigkeit zu interdisziplinärer Zusammenarbeit
• Ausgeprägtes Qualitäts- und Prozessbewusstsein
  
  
  

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe

The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.

The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.

We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Hameln

Hameln is a renowned contract manufacturer which supplies both national and international pharmaceutical companies. It has over 450 employees who produce sterile medicinal products, mainly for use in hospitals and intensive care facilities.

Main activities

• Contract manufacture of parenteral solutions and suspensions – aseptic or terminally sterilized in ampoules and vials
• Specialist in the production of complex preparations such as anesthetics, flammable and oxygen-sensitive liquids and cold chain products
  
  
  

Special features

• Successful transfers and establishment of new products in sterile production
• Batch size: up to 3500 liters
• Clean room area: 4000 m²
• Batch manufacture and filling of sterile products, from visual inspection through to final packaging
  
  
  

Strategic importance

• Contract manufacturing for parenterals