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Quality Assurance Specialist GCP

CTC Resourcing Solutions

 
Basel area, Switzerland
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Our client is an innovative mid-size Pharmaceutical company with global headquarters in the German speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognised institutions. They currently market 3 leading products in anti-infectives and oncology via a global alliances and extensive partner network. We have a long standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there.

Quality Assurance Specialist GCP

Main Responsibilities:

  • Write and review clinical QA related documents
  • Manage sub-contracting of external audits at vendor/investigator sites
  • Organize and prepare internal GCP/PV audits according to approved schedule
  • Divers administrative help for QA team
  • Edit and review GxP documents
  • Manage the external audit contractors (e.g. contract writing, contract amendment writing, WO preparation, price proposal requests etc ..)
  • Ensure the scheduling, planning, preparation, performing/reporting and follow-up on audits at vendors, investigator sites and CROs
  • Support Quality Managers and Quality Specialists in Quality Unit with tracking of GxP relevant documents/tasks (e.g action items)
  • Act as contact person for vendors and internally in respect to administrative QA issues
  • Deputize for QA Specialist

Qualifications and Experience:

  • Strong IT-skills, especially with Word, Excel and document management systems
  • GCP/PV basic knowledge knowledge
  • Experience with review of GxP-documents
  • Service-oriented
  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • A minimum of 1 years of experience in the Pharmaceutical Industry and a minimum of 1 year in a GCP/PV QA environment
  • Experience in handling GxP documents
  • Experience in documentation and archiving
  • Good communication skills
  • Ability to work in different cultural environment
  • Multitasking abilities
  • Skills in working in IT systems.

 

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

E-Mail

Website http://www.ctcresourcing.com

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