Clinical Trial Supplies Project Associate - Amadora

Ort: Portugal - Amadora

Funktion: Research and Development

Firma: Vifor Pharma

Brenda Nauli

International Talent Scout

+41 58 851 83 69

Richtlinien für Agenturen

Ihr 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.

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