Location: Switzerland - St Gallen
Company: Vifor Pharma
Drawing on a keen understanding of quality processes for production, information technology and operational excellence, the quality process champion will introduce the harmonized Manufacturing Execution System in the quality organization of Vifor Pharma. In a role focusing on release by exception, you will operate as the interface to manufacturing and IT to jointly digitalize the batch records. Based at corporate quality in St. Gallen you will overview all Vifor Pharma manufacturing and release site. Your tasks can be described as follows:
- Drive the introduction of the Manufacturing Execution System (MES) in the quality organization
- Contribute to drive the cross site process harmonization process
- Digitalize all batch record release processes while meet all data integrity requirements
- Provide cross-company support for all Vifor Pharma site with regard to quality process optimization and operational excellence
- Train involved staff on the system landscape
- Managing, maintaining and controlling the Manufacturing Execution System
- Build up the know-how to become the quality competence center for Manufacturing Execution System within Vifor Pharma
- Bachelor’s degree in technical field (Science, Business Administration, Engineering …)
- Minimum 5 years’ experience in operation function within the pharma industry or similar industry (i.e. food, medical devices, …)
- In-depth understanding of business processes from launch of the production order to the final release
- Good understanding of laws and guidelines such as GMP, GDP, GAMP5 …
- Project management experience in process harmonization – optimization
- Understanding of IT environment
- Experience in the MES System, PAS-X by Werum (Germany) preferred
- Demonstrated ability to successfully collaborate and negotiate across different sites, functions and management levels
- Excellent change management leadership skills
- Good knowledge of IT system landscape within a manufacturing environment
- Fluent in English and German (written and verbally)
- French and Portuguese would be an asset
This position is based in St.Gallen but you will collaborate across countries and Teams.
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.