QUALITY ASSURANCE AND DEPUTY RESPONSIBLE PERSON- ROMANIA

Ort: Romania - Cluj

Funktion: Quality Management

Firma: Vifor Pharma

Elena Voigt

International Senior Talent Acquisition Consultant

+41 58 851 80 40

Richtlinien für Agenturen

Ihr 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

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/über-vifor-pharma/wer-wir-sind

Inhalt ein-/ausblenden

Bewerben
Teilen
LinkedIn Xing Send to a friend

Richtlinien für Agenturen