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Qualified Person

December 12th 2019

Passion & smart processes: Une performance contagieuse pour des vies meilleures. Novasep est plus qu’une entreprise, Novasep est une seule et grande équipe où chacune et chacun contribue jour après jour à la construction d’un meilleur futur. Notre mission est de co-céer avec nos clients des solutions professionnelles adaptées à leurs besoins et contribuant au développement de leurs activités de façon durable, mais pas seulement… notre mission est également d’améliorer la qualité de vie des patients de nos clients. Notre culture repose sur l’intégrité, l’innovation, l’engagement et l’esprit d’équipe afin d’être reconnu comme partenaire de choix par nos clients. Chez Novasep, chaque membre de l’équipe est un ambassadeur de cette mission selon ses talents et aspirations personnelles. Et bien entendu, chez Novasep il y a du fun et nous y célébrons nos succès ! C’est pourquoi nous voulons que vous vous joigniez à nous pour participer à ce beau projet.

Mission Description

The QP is the person responsible for the final release of a batch of pharmaceutical product, finished products that are ready for consumption only. To do this, they must review all of the batch files, which encompass information from the other departments.

Main Responsibilities

  • Before certifying a batch prior to release the Qualified Person doing so should always ensure that the following requirements have been met:
    • Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released for sale or supply in the EC/EEA or for export
    • The principles and guidelines of GMP as stated in Directive 2003/94/EC for medicinal products and IMP for human use, as interpreted in the EC Guide to GMP have been followed.
  • Ensure all requirements under references have been met prior to release of a batch
  • Ensure the principal manufacturing and testing processes have been validated
  • Ensure All the necessary Quality Control checks and tests have been performed, and account taken of the manufacturing and packaging conditions including a review of batch records
  • Ensure all necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes
  • Ensure all necessary manufacturing, packaging and quality control documentation has been completed and endorsed by suitably authorised staff.
  • Ensure that the legal requirements regarding imported products have been fully met
  • Ensure the general conditions as laid down on the Manufacturer's License orManufacturing Authorisation (IMB) are followed
  • The QP should maintain their knowledge and experience up-to-date in the light of technical and scientific progress and changes in quality management relevant to the products which they are required to certify
  • The QP must carry out audits of GMP facilities involved in the manufacturing of medicinal products used in the clinical study
  • The QP must maintain a register of all released batches
  • The QP must promote GMP through training and guidance internally

 

Candidate profile

The QP is named on a manufacturing licence and must be qualified according to Directive 2003/94/EC.
This is granted by taking a specific 2 year course, or by having a Pharmacy degree plus the required experience.
Minimum of five years experience in a Quality role.
Bilingual French/English (both written and oral)
MS Office Suite (Excel/Word/Powerpoint)

 

Offer

Type d'emploi : Emploi à durée indéterminé 
Lieu principal : Europe-Belgique-Gosselies     
Horaire : Temps plein
Equipe : Travail de journée

Détails en direct avec la société.

Contact Details

Merci d'envoyer votre candidature à l'adresses suivante : laure.mariscal-ext@novasep.com en mentionnant cette référence 1900009I ou postuler en ligne via ce lien.