Clinical Trial Supplies Project Associate - Amadora

Lieu: Portugal - Amadora

Fonction: Research and Development

Compagnie: Vifor Pharma

Brenda Nauli

International Talent Scout

+41 58 851 83 69

Conditions pour les agences de placement

Votre profil

In this position, you report to the Clinical Trial Supplies Project Manager and support the management of all activities related to IMP Packaging at our manufacturing site in Lisbon. Your responsibilities are the following:
  • Support the establishing of processes and SOP’s to set up a new, efficient internal IMP Packaging site as per current standards
  • Support the creation and maintenance of all Packaging Documentation for assigned studies based on packaging request from HQ Clinical Trials Supply Management Team, in alignment with protocol requirements, key study parameters and milestones
  • Provide up to date project timelines for each packaging campaign, to book packaging slots for timely packaging, and to make sure all required products are available in time
  • Oversee and perform line unit checks of GMP documentation
  • Perform housekeeping activities and documentation as assigned by Clinical Trial Supplies Management Team at HQ, and by Clinical Trial Supplies Project Manager, or by internal manufacturing specialists
  • Develop and evaluate blinding strategies
  • Support label proof approvals processes
  • Support timely ordering of packaging materials, labels and booklets, auxiliary materials and comparators
  • Oversee the local inventory, to provide reports as requested, and to support reconciliation processes as needed
  • Identify, assess and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
  • Support optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions
  • Support an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies
For this role, we are looking for a reliable and rigorous person bringing the following profile:
  • University degree in Lifesciences, Pharmacy, Biochemisty, Chemistry or similar
  • At least 2 years’ experience in a similar Clinical Trial Supply Management position, within a global pharmaceutical or biotech industry
  • Very good knowledge of GMP, GCP and GDP compliance requirements
  • Fluent in Portuguese and English both in oral and written conversation
You are a flexible and well organized person, able to perform under pressure. Used to work in cross functional organizations, you hold strong communication skills that help to work efficiently with others. You want to embrace a new challenge and to take on new responsabilities.

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