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Responsible person (according to tpa/mlpo)

Sempach
Festanstellung
B. Braun Medical
Inserat online seit: Veröffentlicht vor 17 Std.
Beschreibung

Are you a seasoned pharmaceutical quality professional with a strong understanding of Swissmedic regulations and GDP/GMP standards? B. Braun Medical AG is seeking a Responsible Person (RP / FvP) to ensure compliance with Swiss pharmaceutical legislation and uphold the highest standards of product safety and quality.As the RP, you will hold legal accountability for the release of medicinal products, pharmacovigilance, biovigilance, and regulatory compliance. You will act independently in all decisions related to product quality and safety and serve as the primary contact for Swissmedic and other regulatory authorities.

Your Tasks & Responsibilities

* Independently release or reject medicinal products and market returns
* Oversee pharmacovigilance and biovigilance systems, including case management and safety communications
* Ensure compliance with GDP, GMP, and Swissmedic requirements
* Advise internal teams on pharmaceutical compliance and safety topics
* Conduct supplier audits and ensure readiness for inspections
* Act as Local Drug Safety Officer (LDSO), QPPV (veterinary), and Biovigilance Responsible
* Serve as IMS Process Owner and Coordinator for assigned processes

Your profile

* University degree in Pharmacy, Life Sciences, or a related field
* Recognized qualification and experience as a Responsible Person under Swissmedic guidelines
* In-depth knowledge of Swiss pharmaceutical legislation (HMG, AMBV) and GDP/GMP standards
* Strong decision-making and communication skills
* Fluent in German and English (French is a plus)
* Trustworthy, independent, and committed to continuous improvement

Our offer

This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!

Benefits

* Open and pleasant working atmosphere
* Flat hierarchies and efficient structures
* Flexible working time and home office possibility
* Possible development opportunities
* Active health promotion by supporting external health offers
* Supporting families through our "B. Braun for Family " program
* Various employee benefits e.g., for lunch and more

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