Job Description

Summary:

An exciting opportunity has arisen to join Research & Development Quality and risk management (RDQRM) department for QMS compliance activities. The RDQRM department has a key role in the continuous improvement process in Healthcare R&D. In this position, you will support the management of quality issues, root cause analysis and the implementation of corrective and preventive actions (CAPA). This includes maintaining our processes and ensuring our electronic Quality Management System (eQMS) is current, thereby guaranteeing the integrity of our data.

Your role:

Maintain assigned quality issues and CAPAs within the eQMS

Provide support to internal customers regarding assigned records in the quality issue and root cause/CAPA processes

Contribute to the monitoring processes and continues improvement of the Quality Issue and CAPA processes, including enhancements to our eQMS

Oversee data quality for assigned areas

Drives quality into the business through proactive quality support

Have a keen attention to quality and detail

Who you are:

  • Master degree/PhD in natural science or equivalent education preferably with quality management experience
  • Expertise in continuous improvement with background in appropriate tools/procedures
  • Excellent communication skills in written and spoken English
  • Display high learning agility and self-motivation, coupled with a critical mindset.
  • Possess basic knowledge of GxP quality systems and safety-related regulations (clinical trials and post-marketing settings).
  • Proficient in the Microsoft suite of applications.
  • Exhibit strong intercultural and teamwork skills, with experience working across cultural and functional boundaries, including virtual collaboration
  • Possess excellent problem-solving and organizational skills, with the ability to prioritize tasks and adapt swiftly to changing priorities.

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