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Local Quality Standards Expert

vor 1 Woche


Bulle FR, Freiburg, Schweiz Randstad (Switzerland) Ltd. Vollzeit
Key Responsibilities

The Bio DS Local Quality Specialist will be responsible for the following key tasks:

- Overseeing product documentation to ensure full product knowledge and implementing improvements in response to business needs, operational excellence, quality, or regulatory requirements.

- Leading the site Change Control Committee, ensuring smooth and coherent management of changes and regulatory impacts. Actively supporting site manufacturing and supply activities, particularly product changes, in compliance with GxP and UCB quality standards.

- Driving and developing the on-site quality culture, influencing teams to embed quality practices into daily activities. Providing support and expertise in quality systems to help business partners fulfill their quality responsibilities.

- Approving and authorizing quality SOPs, Change Control, deviations, and related documents, while maintaining oversight of product-related documentation. Contributing to the efficient follow-up of product-related change controls by managing relationships with internal and external stakeholders, including CMOs.

- Reviewing and approving validation protocols, CPV (Continuous Process Verification) reports, and Product Quality Reviews (PQRs). Contributing to investigations when necessary, ensuring effective follow-up of deviations, incidents, investigations, and CAPAs (Corrective and Preventive Actions).

- Actively contributing to simplifying and streamlining processes to remove obstacles and support continuous quality improvements. Participating in quality strategies for projects within your area of responsibility, providing support and expertise as needed.