QUALITY ASSURANCE SENIOR MANAGER 100% - Lisbon

Ort: Portugal - Amadora

Funktion: Quality Management

Firma: Vifor Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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Ihr Profil

In this position, you actively work for the Quality Management Department and lead the Quality unit of the mono product facility. You establish all necessary processes and SOPs in alignment with the Site Quality System and lead transformation process towards an FDA approach and culture. Your responsibilities include:

  • Management and leadership of the quality aspect of the products and the facility
  • Supervision of the EU/FDA Quality related topics within the context of the implementation of a specific new pharmaceutical manufacturing unit
  • Ensure GMP/GDP/FDA inspection readiness on the new unit together with the site common systems, respecting agreed timelines
  • Manage for audits and inspections for the new unit related topics
  • Execute and support all Quality related activities in this context: Issue / review documents, audits / inspections; internal and supplier audits, training sessions, maintenance of databases, management of GMP/GDP/FDA related IT systems, definition and management of CAPAs, elaboration of Quality Reports based on Risk Analysis approach
  • Train staff and management to fulfill GMP requirements
  • Actively participate in different projects
  • Work in accordance with EU/FDA GMP guidelines and other applicable legislation

For this challenging position, we are looking for an innovative and hands-on person bringing the following profile:

  • University degree in pharmaceutical sciences, chemistry, or similar
  • More than 5 years’ experience in Pharmaceutical Industry within an EU/FDA GMP environment
  • At least 3 years’ experience in a management function
  • Strong experience within quality assurance functions
  • Proven ability to manage EU/FDA audits and inspections
  • Auditor Qualification, knowledge of statistic tools; Lean 6 Sigma training are assets
  • Knowledge of Microsoft tools (e.g.: Word, Excel, PowerPoint)
  • Fluency in English and Portuguese (written and spoken)

You hold strong communications skills and are able to communicate with all internal and external stakeholders. Comfortable with team working, you like to embrace new projects and to coordinate the activities. You describe yourself as a goal-oriented and customer-oriented person, who works efficiently under pressure and easily develop new pragmatic solutions. Thanks to your leadership, you know how to convince and influence people.

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

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