Specialists in Pharma, Clinical & IT Recruitment

GCP Quality Manager

Reference:
RB05
Job Type(s):
Quality Assurance
Salary:
£60,000 to £80,000 Per Annum
Town/City:
Germany
Contract Type:
Permanent
Date Posted:
20/12/2012 11:42:00
Start Date:
20/12/2012
End Date:
31/03/2013

Description

The Company 
My client is an independent research-based biotechnology company in Germany who are growing sustainable pipeline of antibody therapeutics targeting solid cancers with high medical need and large market potential. They are looking for a GCP Quality Assurance Manager to join them at their site in west Germany
 

The Role

  • Quality assurance of clinical trials in Phases I-III, pharmacovigilance activities, as well as clinic-accompanying biomarker programs
  • development of the existing quality system in accordance with GCP area of ??the development of clinical research
  • support to the creation and implementation of SOPs (Standard Operating Procedures) and in the development and maintenance of quality documents
  • Planning, preparation and execution of internal and external audits (CROs, suppliers, etc.) in the GCP area.
  • Creation of audit reports and tracking (CAPA)
  • ensure continuing and corporate GCP-compliant training / training of all employees

 
The Requirements

  • Successfully completed a science degree
  • Several years of experience in clinical research experience in quality assurance activities for clinical development, including auditing of systems, processes and services
  • Prior expeirence in Oncology is advantageous. 
  • Excellent knowledge of all relevant international and national regulations and regulatory requirements
  • Fluent in English and German written and spoken
  •  Ability to work precisely  and in depth detail

If you or anyone you know might be interested in this role- please do not hesitate to contact Reesa Berry on +441483 397070 or send an email to reesa@arc-7.com

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