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Aye (Marche-en-Famenne), Belgium

QA Officer - GMP (M/F)

  • Experience 3 to 5 years 5 to 7 years 7 to 10 years 10 years or more
  • Type of role Quality, Security & Environment
  • Region Wallonia
  • Activity CRO - CDMO

Contact Anaïs Van Meerbeck
Email
+32 (0)471 81 91 26

More info on Orgenesis

Orgenesis aims to provide life changing and affordable treatments to patients. Orgenesis is a pioneering global biotech company featuring a unique Cell & Gene Therapy Platform.

Its platform is shaping a CGT ecosystem to lower costs for innovators, accelerate treatments to market, and expand access for patients. Its innovative platform consists in a pipeline of therapeutics; customized technologies; and a global network of leading companies, research institutes and hospitals. Learn more about the work Orgenesis is doing at www.orgenesis.com

In order to support the rapid growth of Orgenesis (Belgium), we are looking for a (M/F) : QA Officer - GMP.


Responsibilities:

Reporting to the Head of Quality Assurance, you contribute to the company’s QA activities. You ensure the compliance with the appropriate standards and regulations. This includes the development of the QMS, procedures, QA operations and continuous improvement projects.

Your main responsibilities are:

  • You support the QMS management according to GMP standards and relevant regulations.
  • You ensure that the QMS processes are documented, implemented and updated.
  • You participate to the reception and release process of raw materials and consumables.
  • You take part to suppliers’ and service providers’ qualification.
  • You execute Internal QA audits and report results to the management.
  • You maintain iQMS system and report issues to the QA manager.
  • You review and participate to Deviation, CAPA, Change Control, OOS and OOT investigations.
  • You prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including EM, Pest Control, Quality KPI, recalls and corrective actions.
  • You participate to the elaboration of AQR/PQR reports.
  • You review Risk Management records and maintain Site Risk Register updated.

Profile:

  • Bachelor’s or master’s degree in sciences, or equivalent through experience.
  • You show at least 3 years’ experience in a QA position within the Pharma/Biotech industry.
  • ­A GMP manufacturing experience is a plus.
  • You are smart, autonomous, analytical, rigorous, and team player.
  • You possess an efficient communication and sense of ethic.
  • Result, Science, Solutions and Quality minded.
  • Good communication skills in English. The command of French is an asset.

Offer:

  • A full-time permanent contract.
  • The opportunity to join an international and multicultural biotech with strong expertise.
  • A human-sized work environment with a convivial atmosphere.
  • An attractive salary package including a company car, health insurance, meal vouchers, etc.
  • An eco-friendly workplace at Novalis Science Park (Aye – Marche-en-Famenne).

Your application and related information will remain strictly confidential.

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