Location: Portugal - Amadora
Function: Research and Development
Company: Vifor Pharma
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.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives. Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world. The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are.