Clinical QA Assurance Specialist - Switzerland
- 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.
- 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