Quality & Compliance Specialist

Experis IT
Bruxelles (BE)
vendredi 28 décembre 2018
Date limite
lundi 11 février 2019
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
Temps de travail
Temps plein

Quality & Compliance Specialist

Primary purpose of the role

  • Supporting an efficient and smooth distribution of high-quality products to the market.
  • Responsible for compliance to regulatory requirements for wholesale distribution of medicinal products, diagnostics and medical devices for the different customers.
  • Supporting the Q&C Manager in the maintenance and improvement of quality standards, in line with regulatory and customer requirements. Advising in the translation of GMP, GDP, ISO and customer requirements in processes, procedures and instructions. Supporting operations in the investigation of issues and advising for the corrective and preventive actions to prevent reoccurrence. Participating in risk assessment exercises.

Key Accountabilities:

  • Batch release: To prepare the dossiers needed by the delegated QP/RP for the release of products. An emphasis on product quality and compliance is required above all, but this needs to be combined with attention for lead times, logistic priorities, and timely communication in case of potential supply issues as a result of quality-related issues.
  • Legal permits and agreements: To perform the administration needed top obtain the necessary legal permits and declarations needed for release of goods into Europe and wholesale distribution activities.
  • Returned Goods handling: To execute assessments of the product quality of returned goods and document accordingly.
  • Deviation resolution: Handling of temperature excursions: to prepare an immediate and correct impact assessment of temperature excursions on product.
  • Customer care: Providing support to various internal and external customers.
  • Environmental Monitoring, pest control, cleaning: To authorize the environmental data generated in the distribution operations and to access potential product impact of potential excursions. To authorize the pest control and cleaning schedules for the site.
  • Quality Systems: To support the implementation of the quality systems needed in the operations. The warehouse receives drug products from our client(s). These drug products are then distributed to more then 90 countries in the world. The warehouse is also managing the detail distribution of drug products to the wholesalers in Belgium, the Netherlands and Luxembourg.

Your profile:

  • Minimal 3 year experience in Pharmaceutical Industry in a Q&C role;
  • Operational knowledge of good distribution practices and regulations;
  • Knowledge of quality techniques and quality management systems;
  • Knows to combine accuracy with urgency;
  • Problem-solver;
  • Prepared to take responsibility;
  • Is able to deal with changing priorities in a flexible manner;
  • Communicative;
  • Excellent written and spoken French, Dutch and English;
  • Be able to work individually and independently within a team.

Keywords : “Quality”; “Compliance”; Specialist” ; “Pharmaceutical”; “Quality Systems”; “GMP”;”GDP”;”ISO”.

Please apply directly to diane.louppe@exepris.be or 02 379 11 76.