QUALITY ASSURANCE AND DEPUTY RESPONSIBLE PERSON- ROMANIA

Lieu: Romania - Cluj

Fonction: Quality Management

Compagnie: Vifor Pharma

Elena Voigt

International Senior Talent Acquisition Consultant

+41 58 851 80 40

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Votre profil

Due to the growth of our Romanian affiliate, we are now looking for a Quality Assurance and Deputy Responsible Person to join our team in Cluj. In this newly created role, you will be responsible for acting as a deputy to the qualified/responsible person onsite as well as ensuring GDP compliance.  You will also be responsible for the following tasks:

  • Develop  procedures and establish effective processes in relation to all Vifor Pharma Romania activities
  • Ensure that medicinal products are procured, held and supplied in a way that is compliant with the requirements of GDP
  • Ensure products are delivered to the right recipients within a satisfactory time period
  • Ensure that initial and continuous training programmes are implemented and maintained
  • Ensure self-inspections/ internal audits are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
  • Establish a change control system and incorporates quality risk management principles
  • Measurement of the achievement of quality system objectives;
  • Assessment of performance indicators used to monitor the effectiveness of processes within the quality system, such as complaints, deviations, CAPA, changes to processes; feedback on outsourced activities; self-assessment processes including risk assessments and audits; and external assessments such as inspections, findings and customer audits
  • Coordinate and provide quality documents to clients
  • Deal with relevant customer distribution and product quality complaints, returned, rejected, recalled or falsified products
  • Approve returns
  • Ensure suppliers and customers are approved
  • Keep appropriate records of all distribution activities
  • Comply with the PD on National Regulatory Product Information regarding the revision of Product Information in accordance with local procedure and local regulatory requirements
We are looking for a flexible, results-oriented and proactive person. To be successful in this role, you bring the following profile:
  • Qualified Pharmacist
  • 3 to 5 years of previous distribution experience within the pharmaceutical industry
  • Knowledge of the Good Distribution Practices and the Romanian Law
  • Experience working with quality systems
  • Audit training and certification
  • Very good communication skills in English and fluent Romanian

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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Conditions pour les agences de placement