(Senior) Manager – Quality operations and Deputy Responsible Person (RP)
Join to apply for the (Senior) Manager – Quality operations and Deputy Responsible Person (RP) role at Fresenius Kabi SwissBioSim.
We have a clear commitment: putting best‑possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
Functional Goal: This position has primary responsibility to ensure that the Medicinal Products traded by FKSBS Business Unit (BU) Pharma & Nutrition are in continuous compliance with applicable law and regulations (GxP, ICH, ISO especially ISO9001).
Main Tasks:
* Manage the applicable GDP quality tasks and support the GMP activities to trade Medicinal Products for BU Pharma & Nutrition.
* Maintain an up‑to‑date knowledge of cGxP regulations and applicable standards (especially in the US and EU) and support implementation of requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc.).
* Act as deputy RP, i.e. support the GxP activities for commercial medicinal products traded by FKSBS; support the RP for the GDP‑related quality tasks; contribute to the maintenance of Quality Systems related to the Swissmedic Establishment Licenses.
* Support FKSBS BU Pharma & Nutrition and TPMs due diligence & suppliers qualification activities, including managing Quality Agreements and conducting Audits.
* Oversee the collection and processing of Events, Changes, CAPAs liaising with the relevant functions of the respective Business Unit, other Fresenius Kabi entities and Suppliers. Notify management of events requiring immediate attention/action.
* Develop and Collect Key Quality/Compliance Indicators for periodic review of local Quality management system and regular communication with Supply Chain.
* Contribute to continuous improvement of quality processes associated with Medicinal Products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls.
* Identify training needs for the BU Pharma & Nutrition team at FKSBS.
Other Tasks:
* Contribute to internal audits, self‑inspections and Health Authorities inspections.
* Support GMP / GDP / MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers.
* Manage the Quality Management Reviews for BU Pharma & Nutrition.
Your contact
Elisa E. Arnaud (On Leave)
Fresenius Kabi SwissBioSim GmbH
Eysins
Kennziffer R-10014327
career.fresenius.com
fresenius.com
fresenius-kabi.com
All job applicants are welcome. All terms used in this job advertisement to denote persons refer to all genders equally.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Research
Industries: Research Services
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