Quality Assurance Specialist in Villars sur Glane

veröffentlicht
Kontakt
Mayank Chaubey, Basel Professionals Health Care & Life Sciences
Jobtyp
Temporary
jetzt bewerben

job details

veröffentlicht
Ort
Villars sur Glane
Sektor
Life Sciences
Jobtyp
Temporary
Referenznummer
11017
Kontakt
Mayank Chaubey, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50
jetzt bewerben

Stellenbeschreibung

For our client located in Ettingen, we are looking for a

CLINICAL QUALITY ASSURANCE MANAGER/AUDITOR - SWITZERLAND, EUROPE AND/OR HOME OFFICE BASED to join our clients team in Switzerland. You can either work from our offices in Switzerland or possibly from varied client offices locations in Switzerland.

Responsibilities:

  • 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

Skills:

  • 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

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. 
  • Ability to work independently and collaboratively in a challenging regulatory environment as part of an experienced team of auditors.

If that interest you then we are looking forward to receiving your application with the following:

  •  
  • Your CV in German/English
  • Latest Work Certificates
  • Your Motivation Letter
  • Date of your availability
  • Copy of your work permit

Apply now to be considered – Good to know you!

For more information and your application, please contact:

Mayank Chaubey, PhD

Consultant Professionals Life Sciences Randstad (Suisse) SA

T +41 58 201 55 62 M +41 79 513 24 83