CLINICAL QUALITY ASSURANCE MANAGER/AUDITOR - SWITZERLAND, EUROPE AND/OR HOME OFFICE BASED

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Quality Management

Firma: Vifor Pharma

Lucie Kulhanek

Senior Talent Acquisition Specialist

+41 58 851 83 68

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We are currently looking for a Clinical Quality Assurance Manager/Auditor to join our Quality Management team in Switzerland. You can either work from our offices in Switzerland or possibly from other Vifor office locations in Europe, consideration will also be given to home office based European candidates.

Your responsibilities will include:
  • Independently conduct external & internal audits for QM CMRS (incl. for-cause audits)
  • Monitor audit responses and corrective action to ensure accuracy and completeness
  • Act as CQA Auditing representative in designated clinical study teams and provide internal guidance and consulting for trial GCP and related regulatory  issues
  • Act as CQA Auditing representative for study documents compliance verification (e.g. product specific/trial specific ICF, protocol, CSR, IB, CRF etc.)
  • Involvement in QM CMRS audit CAPA management (tracking, oversight, follow-up, closure)
  • CQA Audit documentation management and maintenance (including audit database and trial and global audit plans)
  • Lead and/or contribute to Quality Risk Management (QRM) activities in Clinical trials
  • Keep QM apprised of compliance and personnel issues through periodic reports
  • Generate and provide metrics, status and other information in relation with GCPand GVP, as required by management
  • Perform other duties as assigned, e.g. GCP training, support of Head QM CMRS, Head CQA
  • Auditing and Head PV QA in Regulatory Authority inspection preparation, conduct and post-inspection activities
We would like to welcome the following experience and skills for the role:
  • University degree or equivalent in health sciences, nursing, pharmacy or related field
  • Minimum of 2 years’ experience in GCP auditing with FDA/EMA/Global regulatory requirements and ICH guidelines (monitoring or clinical operations experience are acceptable)
  • Experience in regulated environment, preferably pharmaceutical or CRO industry
  • This role involves minimum 20%-40% travel
  • Preferred Requirements: Ability to work independently and collaboratively in a challenging regulatory environment as part of an experienced team of auditors
You describe yourself as a dynamic and flexible person with good communications skills. With the ability to work independently and collaboratively in a challenging regulatory environment as part of an experienced team of auditors.

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

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