GxP Compliance Expert (m/f/d)

jobcourier.ch; Kaiseraugst; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Benefits dieser Stelle

Parkmöglichkeiten vor Ort

Mensa/gekochte Mahlzeiten vor Ort

Weiterbildungsunterstützung

Moderne Arbeitsumgebung

Zusammenfassung

Work Selection AG sucht zur Unterstützung unseres renommierten Geschäftspartners F. Hoffmann-La Roche Ltd. in Kaiseraugst einen GxP-Compliance-Experten für eine befristete 12-Monats-Anstellung mit hoher Aussicht auf Verlängerung.

Die Aufgabe umfasst SME-Funktionen in GxP, Compliance-Beratung, Dokumentenverwaltung und Qualitäts-KPI-Besitz. Sie verfügen über ein abgeschlossenes Studium (BA/MS/MBA) in einem relevanten Bereich sowie mindestens 6 Jahre Berufserfahrung, tiefe Kenntnisse in cGMP,

Qualifikationen

• Abgeschlossenes Hochschulstudium (BA/MS/MBA) in relevanten Feldern.
• Mindestens 6 Jahre Berufserfahrung im GxP-/Qualitätsbereich.
• Fundierte Kenntnisse in cGMP und regulatorischen Inspektionen (FDA/EMA).
• Verständnis end-to-end Supply Chain, Lager/Transportlogistik, klinische Supply Chain.

Aufgaben

• GxP-Compliance- SME für alle Themen; Beratung und Systemadministration (z. B. Veeva-Dokumentation).
• Audit-/Inspektions-SME für Deliver-Examinations.
• Bearbeitung von Abweichungen, CAPAs, Changes & Process Improvements.
• Qualitäts-KPIs verantworten und Deviation-Management verbessern.

Kenntnisse

GxP Compliance

Regulatory Inspections

Audit & Inspection

Quality Systems

Ausbildung

BA/MS/MBA in Life Sciences or SCM

Tools

Veeva

Cornerstone

MS Office

Visio

Google Apps

Jobbeschreibung

Work Selection AG

As a first-tier supplier to our renowned business partner F. Hoffmann-La Roche Ltd. in Kaiseraugst, we are currently looking for a motivated and dedicated GxP Compliance Expert for a temporary assignment of 12 months, with high probability of extension.

Tasks & Responsibilities

• SME for all GxP and compliance-related topics (proactive advice on these matters) incl system administration (Veeva quality docs)
• Audit/Inspection SME for Deliver for non-study specific examinations
• Processing of deviations as well as CAPAs, Changes, Process Improvements
• Quality KPI Ownership for Deliver
• Responsibility for deviation management improvement processes
• Offer comprehensive compliance expertise to the business, conducting Root Cause Analysis (RCA) to identify and address quality, regulatory and compliance-related issues
• Managing the structure for the departments& SOPs and any other regulated documents (The business know-how is provided by the chapter's SMEs)
• Responsibility for trend reporting across Quality and Compliance requirements
• Implementation of GxP training and further development of employees& GxP knowledge

Must Haves

• You hold a degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management), backed by significant expertise and extensive years of senior professional experience.
• At least 6 years of professional experience
• You possess extensive knowledge of cGMP standards alongside hands-on experience navigating internal (PTQ, Pharma-Technical Quality) and external (e.g., FDA, EMA) regulatory inspections.
• You bring a deep understanding of end-to-end supply chain management, specifically encompassing warehouse and transportation management, logistics, and clinical supply chain distribution processes.
• You demonstrate strong interpersonal, communication, organisational, and prioritisation skills with a steadfast focus on customer needs.
• You are fluent in both written and spoken German and English.
• You are proficient in using Google applications, MS Office (Word, Excel, PowerPoint), Visio, and key industry systems such as Veeva and Cornerstone.

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card

Wir wertschätzen Vielfalt und begrühsen daher alle Bewerbungen ? unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Temporär

100%

Mitarbeiter

Branche: Anderes

Funktion: Anderes