B. Braun Medical AG
Responsible person according to TPA/MLPO & Responsible Person for Advertising
📍 Sempach
Rolle und Verantwortlichkeiten
Independently release or reject imported medicinal products (Swiss market release) and market returns. Ensure compliance with GDP, GMP, and Swissmedic requirements. Oversee change controls & deviations etc. related to medicinal products. Advise internal teams on pharmaceutical compliance and safety topics. Act as Responsible Person for advertising for Swiss market release (release of pharmaceutical advertising material). Act as subject matter expert in Audits / Inspections for the areas of expertise. Ensure readiness for inspections (ISO / GxP). Be involved in pharmacovigilance systems, including case management and safety communications. Serve as IMS Process Owner and Coordinator for assigned processes (market release and advertising processes).
Team / Beschreibung
As a Swiss subsidiary of the globally active B. Braun Group, we are one of the market leaders in Switzerland and offer our more than 1,100 employees exciting prospects. With strong teams, we do valuable work every day. At our production sites in Sempach, Escholzmatt and Crissier, we manufacture solutions that are indispensable in the healthcare sector. This makes us proud.
Qualifikationen und Fähigkeiten
University degree in Pharmacy, Life Sciences or a related field
Recognized qualification and experience as a Responsible Person (acc. to Swissmedic Guideline I-SMI.TI.17d) and responsible person for advertising (acc. to AWV Art. 25)
In-depth knowledge of Swiss pharmaceutical legislation (HMG, AMBV, AWV) and GDP/GMP standards
Strong decision-making and communication skills
Fluent in German and English (French is a plus)
Trustworthy, independent, accountable and committed to continuous improvement