Non-Clinical Quality Assurance Leader

Part-time / Consultant

Published on 14/03/2024

Responsibilities

  • Contribute to meet GLP regulatory compliance for the Test Facility (OECD guidelines).
  • Ensure implementation of processes and systems (e.g. facilities, equipment, personnel, methods, practices, records) according to the GLP non-clinical program of the Test Facility.
  • Support the maintenance and continuous improvements of the QMS system.
  • Prepare and/or review controlled documents (e.g., standard operating procedures, policies, CAPAs, change controls, master schedule).
  • Review of study plans and study reports, amendments and deviations.
  • Prepare the quality assurance program statement of the study plans and reports.
  • Conduct facility-related, study-related and process-related inspections to ensure compliance with applicable GLP regulatory requirements.

Profile

  • A master’s degree in life sciences or closely related fields
  • Prior experience in non-clinical quality assurance and GLP regulations (3+ years)
  • Strong knowledge of GLP OECD guidelines
  • Strong knowledge in non-clinical research
  • Past experience in CRO is a plus
  • Familiar with standard lab techniques (cell culture and molecular biology) is a plus
  • Based in Belgium

Skills
  • Proficiency in both written and spoken English
  • Excellent communication, organizational and scheduling skills, with ability to execute projects on time
  • Solution-oriented way of working, problem-solving and analytical way of thinking
  • Ability for rapid adaptation, pro-activity and autonomy
  • Team spirit and willingness to integrate a small structure where flexibility is a key factor

Offer

Who we are:
Artialis is a European Contract Research and development Organization (CRDO), offering customized solutions from preclinical (in vitro and in vivo), clinical to post marketing, including a wide range of biomarkers to support the development of your healthy ageing products (pharmaceuticals, medical devices, food supplements).

Artialis’ mission is to provide high quality, affordable and innovative services meeting the regulatory requirements accelerating and reducing costs from our partners for their product development to access market. Our values are trust, respect, excellence, and passion.

Artialis is hiring a Non-clinical Quality Assurance Leader who will be responsible for the implementation of the GLP non-clinical compliance program and leading, in cooperation with non-clinical team, GLP certification.

Our offer:
The contract is for a part-time/consultant and hybrid job.
You will be a key player in an enthusiastic, scientific and motivated team, where you can grow and directly contribute to the success of the company.

 

Application

If you are interested in this position, please send a covering letter and CV both in English to hr@artialis.com.

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