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

Lieu: Switzerland - Glattbrugg/Zurich

Fonction: Quality Management

Compagnie: Vifor Pharma

Lucie Kulhanek

Senior Talent Acquisition Specialist

+41 58 851 83 68

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Votre profil

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.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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Conditions pour les agences de placement