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Clinical QA Assurance Specialist Plan-les-Ouates Switzerland,  


Posted on : 25 April 2017

Project Description

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.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.Novimmune is seeking a Clinical QA Assurance Specialist for its QA Department in Basel. 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 If your profile matches the above description, please send us your CV, copies of your diplomas and motivation letter in English with reference Clin/QAsp to the following email address hr-recruitment@novimmune.com

Locations

1228 Plan Les Ouates Geneva – Switzerland

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