GxP Compliance Expert

Coopers Group AG

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

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.

Hochschulpraktikant/-in Jurist/-in

Bundesamt für Informatik und Telekommunikation BIT · Zollikofen, BE

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Pictet Asset Management SA · Geneva, GE

Leiterin / Leiter Rechtsdienst des Amtes für Justiz und Gemeinden, 100 %

Schaffhauser Polizei · Schaffhausen, SH

GxP Compliance Expert (m/f/d)

Work Selection · Kaiseraugst, AG

Jurist*in im Asylverfahren 80-100 %

Berner Rechtsberatungsstelle für Menschen in Not · BASEL, BS

Données OFS 2024 —

7'985 CHF / mois

Fourchette : 5'991 – 10'000 CHF (P25–P75), brut avant charges.