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Qualified Person - Pharmacist

Experis | Hainaut | Durée indéterminée, Temps plein

En ligne depuis 10 jours sur Jobat.be

Qualified Person - Pharmacist

Are you driven by being the scientific technical support? Are you passionate about therapeutic products and research? Are you keen to communicate with people within your company and with well-know experts?

Company

Our client is a pharmaceutical company with people passionate and dedicated to their jobs and missions.

Qualified Person - Pharmacist

Description de la fonction

Your responsibilities

  • Perform on time the batch release certification of raw materials, intermediates and final products, in compliance with EU guidelines and MOH requirements ;
  • Act as QP delegate for IMP / clinical studies according to EU Annex 13 guidelines ;
  • Support the QP in the revision and approval of release, product specifications, documentation,… through the appropriate system, per Annex 16, review of change controls and evaluate if communication to AFMPS is needed ;
  • Participate to the Company Global QP meetings ;
  • Participate actively to audits with authorities from various countries ;
  • Support the implementation of site projects for e.g. launches of new products and/or geographies, QC changes methods/ tests in alignment with MOH requirements/ certification,… ;
  • Lead and participate projects linked to release activities (raw materials & finished products) ;
  • Redact declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes, clarification etc...) ;
  • Perform gembas & take part in the improvement of internal processes ;
  • Support release team in reviewing and releasing products ;

Profil

Your profile

  • Master's degree in pharmacist;
  • Experienced with 1 to 3 years in a similar environment;
  • You are registered Qualified person in Belgium : certified by AFMPS (Belgian royal decree of Dec 2006 art 48) - Mandatory;
  • Knowledge of quality systems, EU and FDA regulations, cGMP, GDP, Eudralex, Annex 16, Annex 13;
  • Ability to work in a multi-disciplinary team environment;
  • Fact-based / Critical thinking / Rigor / proactivity / Stress-resistant;
  • Good organizational, planning and communication skills;
  • Learning attitude and continuous improvement mindset;
  • Computer skills: MS Office (advanced knowledge in Excel is a plus);
  • Fluent French and English (spoken and written knowledge);

Offre

Offer

Our client offers you a permanent contract in a dynamic and ambitions environment. You will be in charge of various responsibilities and you will develop your skills.

Interested? Contact or 02 389 11 76.

Intéressé(e) ?

Experis Belgium
Diane LOUPPE

Hainaut

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Caractéristiques

Exigences

  • Master (Licence, Université ou Enseignement Supérieur de Type Long)
  • Français

Offre

  • Durée indéterminée
  • Temps plein

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