IMP Quality Clinical Packaging

m/f/d, Aargau

You support the end-to-end cGMP activities, maintaining the Right to Operate at the Clinical Packaging Site in Kaiseraugst, ensure the quality of IMP products to meet Health Authority requirements and Company Standards for IMP products. In this role you are assigned as delegate of the Swiss Responsible Person for IMPs (`Fachtechnisch verantwortliche Person, FvP´), and within that role, you are responsible for the lot disposition and certification of IMPs finished products.

Start date: asap; 01.05.2025/latest Start Date: 01.06.2025

Planned duration: 12 months

Location: Kaiseraugst

Tasks & Responsibilities:

Support all quality-relevant packaging processes and collaborate with packaging operations and all relevant interfaces with regard to GMP topics
Partner with stakeholders and provide GMP support to ensure successful delivery of the company goals
Review and release of manufacturing specifications and Batch Records (BR) of finished and semi-finished goods
Manage actively Deviations and Changes
Collaboration through to the management of local and global projects
Actively engage in optimization activities and improvements within IMP Quality Clinical Packaging Switzerland. Coordinate improvement projects and engage in corrective and preventive measures (CAPA)
Build, verify and implement standard documents (SOPs)

Must Haves:

Fluent in both German and English
Min. Master Degree preferably in Life Sciences or Engineering or similar degree
Min. 3 years of experience in the pharmaceutical industry in a quality manager role
Knowledge of cGMP and quality requirements for clinical development phases
Experience in the area of pharmaceutical development such as packaging lines or materials, master data management, quality control or quality assurance is an advantage
Proven track record to work towards outcomes and an innovative manner of solving problems

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