Quality Assurance Specialist

vor 3 Wochen

Bern, Bern, Schweiz Universität Bern Vollzeit
{"title": "Quality Manager", "description": "Department of Clinical Research

The Department of Clinical Research (DCR) is an academic centre and umbrella organization supporting clinical researchers at the University of Bern and the University Hospitals. Our team provides a central organization for expertise, innovation, leadership, contemporary pedagogy, and centralized facilities to support clinical researchers.

Key Responsibilities
  • Coordinate the activities of the Quality Management Team and act as the primary liaison with internal and external stakeholders.
  • Maintain and further develop the existing ISO 9001:2015 certified Quality Management System, including developing and managing key policies and quality documents, CAPA management, risk management, error management, change management, performing internal audits, vendor qualification and staff training on internal quality standards and regulatory requirements.
  • Assist in the preparation for, and act as the primary contact for maintaining ISO certification at the CTU and CIU.
  • Act as the main point of contact and coordinate the preparation and facilitation of external audits and regulatory inspections.
  • Implement and enforce quality policies and processes.
  • Primary contact for QMS support at University Hospital Bern (Inselspital).
Requirements
  • A University degree (or equivalent) in natural sciences or a related field.
  • Experience in quality management in clinical research.
  • Sound knowledge of clinical research and relevant regulations (Human Research Act, GCP guidelines, Federal Act on Data Protection).
  • Attention to detail and proficiency in documentation and record keeping.
  • Ability to coordinate various aspects within a project.
  • Fluent communication skills in German and English (written and verbal).
We Offer
  • A challenging, versatile job in an exciting field of work in an international, dynamic environment with a motivated team.
  • Balanced work-life balance with flexible working hours.
  • Further training opportunities and programs within the university and a wide range of sports activities at 'Uni Sport'.
  • Salary and comprehensive social benefits according to cantonal guidelines.
", "lang_code": "en"}

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