Quality Expert R&D and Global Engineering (m / w / d) •

SCHOTT; Sankt Gallen; Vor Ort; CHF 80’000 - 120’000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen in der pharmazeutischen Industrie sucht einen qualifizierten Spezialisten, der das Qualitätsmanagementsystem im R&D-Bereich leitet. In dieser spannenden Rolle sind Sie verantwortlich für die Entwicklung und Einhaltung von QM-Prozessen sowie die Durchführung interner Audits. Sie bringen Ihre Expertise in der pharmazeutischen Verpackung und Medizintechnik ein und arbeiten eng mit internen und externen Stakeholdern zusammen. Das Unternehmen fördert eine inklusive und vielfältige Unternehmenskultur, in der Ihre persönliche Entwicklung und Ihr Wohlbefinden im Mittelpunkt stehen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Leistungen

Holistic corporate health management

Flexible working hours

Canteen

Access to public transportation

Qualifikationen

• 3+ Jahre Erfahrung in der pharmazeutischen Verpackung oder Medizintechnik.
• Kenntnisse in QMS und Dokumentenmanagement sind erforderlich.

Aufgaben

• Entwicklung und Pflege des R&D QMS zur Sicherstellung der Compliance.
• Durchführung interner Audits gemäß ISO 13485 und ISO 15378.

Kenntnisse

Qualitätsmanagementsysteme (QMS)

Präsentationsfähigkeiten

Moderationsfähigkeiten

Diligente und strukturierte Arbeitsweise

Interpersonelle Kommunikationsfähigkeiten

Ausbildung

Universitätsabschluss in Ingenieurwesen oder Lebenswissenschaften

Tools

ISO 13485

ISO 15378

GDocP

Jobbeschreibung

Job description: About us

Our Business Unit Pharmaceutical Systems is one of the world’s leading manufacturers of pharmaceutical primary packaging and analytical lab services. More than 600 production lines in 13 countries worldwide produce more than 10 billion syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer.

Your Contribution

• You are result-driven and combine the dynamics of a development environment with the diligence required for QM processes.

• You maintain and develop the R&D QMS and ensure compliance.

• You manage the R&D CAPA process and perform internal audits acc. to ISO 15378 and ISO 13485.

• You drive continuous improvement within R&D and on its interfaces.

• You ensure compliant harmonized development documentation.

• You enable your colleagues to be easily compliant to our QMS by guidance and training.

Your Profile

• You hold a University degree in Engineering, Life Science or similar.

• You have 3+ years of working experience in pharmaceutical packaging, medical device, or pharma industry with development environment and contact to QMS acc. to ISO 15378 or ISO 13485 or similar.

• Diligence, proactive and structured independent working belong to your strengths.

• You have knowledge in QMS and document management, as well as GDocP.

• Strong presentation and moderation skills and a drive to accuracy describe your personality.

• You took part in or lead audits, or at best are a certified auditor, preferably ISO 13485 / ISO 15378.

• You have excellent interpersonal and communication skills and enjoy the exchange with internal and external stakeholders fluent in English and German.

Your Benefits

SCHOTT’s openness to promote your further development is just as great as our additional benefits. Ranging from active health management via flexible working hours and hybrid work all the way to corporate pension plans: everything geared to suit your goals and needs. Discover a special corporate culture where everyone has the opportunity to develop their entire potential.

At SCHOTT, you can expect a unique corporate culture where we emphasize equity, diversity, and inclusion. We know: motivated and committed employees are the precondition for the success of our company.

Please feel free to contact us. You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, please send us your application: SCHOTT Pharma Schweiz AG, Human Resources, Kristina Ettemeyer [phone].

*At SCHOTT, it’s your personality that counts – not your gender, your identity, or origin.

We offer:

• Holistic corporate health management.

• Flexible working hours.

• Canteen.

• Access to public transportation.