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Clinical QA Assurance Specialist - Switzerland  

Novimmune (company)


Posted on : 25 April 2017

Project Description

  • The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. 
  • Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. 
  • Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. 
  • The company has also been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.
  • Our company  is seeking a Clinical QA Assurance Specialist for its QA Department.

Main activities:
  • To act as clinical QA representative and provide QA guidance to support the clinical organization in order to ensure compliance with GCP/GPV, and the clinical QA requirements 
  • To maintain and archive the clinical QA documents system, clinical QA systems, protocol deviation, investigations and change control 
  • To follow and track CAPAs related to audit, report metrics and monitor effectiveness 
  • To ensure that all clinical staff are properly trained on SOPs and the industry guidelines and regulations. 
  • To ensure that clinical QA training program and materials are maintained and archived and facilitate the training to clinical organization 
  • To follow and track CAPAs related to inspection, report metrics and monitor effectiveness 

Skills and competencies:
  • Bachelor degree in biological sciences, chemistry, or related field 
  • More than 3 years active experience in Clinical Trials monitoring or Clinical Quality program, and training, CAPAs 
  • Practical working knowledge of GCP/GPV and all related EU & FDA regulatory requirements and ICH guidelines 
  • Ability to work effectively in a fast-paced environment and work effectively as part of clinical organization team 
  • Ability to take pragmatic approach to problem solving 
  • Good verbal and written communication in English and in German or Italian will be an asset, and interpersonal skills 
  • Computers literate 
  • Swiss resident or EU national