Quality Officer - SL0221

The Quality Officer is responsible for contributing to the planning, organization, implementation and continuous improvement of the integrated Quality Management System of LIH,  to ensure compliance with regulatory requirements, ISO norms, Good Clinical (Laboratory) Practice as well as relevant “Best Practices” requirements e.g. for biobanking with the goal to receive and maintain related accreditation and certification, where strategically relevant.
1A-B, rue Thomas Edison, Strassen 1445, Luxembourg
15/02/2021 11:51:26
Key Accountabilities
  • Ensure – in collaboration with the operational and support units – that quality-relevant documents are written, communicated and applied as well as regularly reviewed for continuous applicability.
  • Ensure that non-conformities of the system are documented and relevant actions and improvements are effectively and efficiently implemented.
  • Support the organisation in desiging, implementing and maintaining the business processes under risk-, quality & safety aspects as applicable.
  • Perform regulatory watch and suggest required adaptation of the integrated QMS to ensure continuous compliance with applicable national and international standards and legislation.
  • Collaborate with the Data Protection Office to ensure that data protection is included seemingless into the QMS.
  • Participate in internal and external audits as contact person.
  • Provide support to the Head of Quality and Safety Management in the preparation and follow-up of Management Reviews; the definition, collection and monitoring of KPIs and other items as needed.
  • Promote quality and safety achievements and performance improvement throughout the organization.
  • Participate in the coordination and provision of (internal) training.
  • Participate in risk assessments as applicable.
  • Replace the Quality Administrative Assistant during her absence with administrative tasks within the QSM unit.
KEY SKILLS, EXPERIENCE AND QUALIFICATIONS

Required

  • Bachelor's degree in an applied science (Biology, Chemistry…)
  • 3 years technical working experience in a (regulated) laboratory context.
  • 2 years experience in the application of quality norms (at least ISO 9001 and ISO 17025) in a quality-related function, ideally in a laboratory context
  • Knowledge of quality tools such as risk management, process analysis, lean management
  • Ability to understand and analyse data for evidence-based decision making
  • Good communications skills / able to listen and find compromises
  • Good writing skills
  • Must be proficient in the use of computers and general office software
  • Must speak and write English fluently.
  • Additional fluency in French would be preferred.

Considered as an asset

  • Experience in the implementation and maintenance of an integrated QMS in a lab environment
  • Knowledge of metrology application according to ISO 17025 (demonstrated by relevant training and/or experience)
  • Knowledge of GCP / GCLP regulations
  • Knowledge of health & safefy requirements for laboratories

REF.: VD/QOFF0221/SL/QSMO
CDI - Full time - Start date : Immediate