QUALITY ASSURANCE SENIOR MANAGER 100% - Lisbon

Lieu: Portugal - Amadora

Fonction: Quality Management

Compagnie: Vifor Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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Votre 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.

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