QMS Application Specialist

The Quality System and Training team in Hillerød is looking for a colleague to configure, maintain and support QMS Application systems.

The QA Systems & Learning Department is responsible for assuring that QMS Applications are utilized, validated and maintained to applied Quality processes. This include but are not limited to system administration, process review (QMR) and learning activities.

The position and key responsibilities

The QMS Application Specialist is responsible for the management and/or contribution to all aspects of the EDMS, LMS and/or Trackwise projects involving the analysis, configuration, integration and maintenance of the systems and the system’s interfaces with other corporate enterprise systems. He/she will collaborate and be a key stakeholder for projects and daily deliverables for the Compliance, Support, Quality Assurance and IT departments.

Your main tasks are:

  • Provide quality, timely and accurate QMS System analysis, configuration and support; including daily technical support to users.
  • Plan for and Lead in deployment of new configurations and corrects, documents, and tracks system issues.
  • Create, configure and maintain system user groups, roles, workflows and process solutions.
  • Support Validation through software testing, document generation, and execution of validation test scripts.
  • Maintain application knowledge, including staying current on software capabilities, availability of new functionality, and updates from the application vendors.
  • Develop custom reports and dashboards based on requirements.
  • Create and maintain QMS system documentation including Admin and User Standard Operating Procedures (SOP’s), functional specifications/user roles and training materials, and provides training to end users.
  • Ensure accuracy and completeness of data and implements improvements.
  • Assist information technology to maintain security and integrity controls.
  • Support QMS functions as required in the QMS applications and in facility as required.
  • Provide training in QMS Process and Systems

Qualifications

You have a Bachelor/Master degree in Engineering, Pharmacy, IT or similar and +3 years of experience from the pharmaceutical, biotech or medical device industry. You like to work as an entrepreneur to find new smart ways to fulfill quality requirements. You can develop effective working relationships with stakeholders at all levels and for you, teamwork and collaboration is key to success. You have excellent verbal and written Danish and English Communication skills.

As  a person you are attentive to details and able to independently resolve a variety of issues without close supervision. You are an influencer and a pragmatic person with an open and communicative approach. You have strong analytical skills and enjoy working collaboratively as a strong individual contributor.Finally you are flexible, persistent and you have the ability to find quick and clever ways to overcome difficulties.

Please upload your CV, cover letter and educational certificate latest by 15th of September 2019.

Apply