Sample Manager Large Molecules

vor 3 Wochen

Basel, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Sample Manager Large Molecules** for a temporary contract of 12 months with a possible extension.

The Lab Support and Compliance section belongs to the “Operations Support & Compliance” (OSC) area within the “Synthetic Molecules Technical Development” (PTDC) at the Basel Site. The area is responsible for late stage technical development of our Synthetic Molecules pipeline of Drug Substances (DS) and Drug Products (DP) for clinical trials.

The section provides key support activities for internal partners such as PTDE, responsible for the development of large molecule products, e.g. parenterals. In this context, the section is responsible for the smooth sample coordination between the logistics area and the various partners (CSC, production, various analytical laboratories, stability management, etc.).

**Tasks**:

- ensure on-time and compliant sample flow between manufacturers (incl. CMO) and Sample Office (PTDC-T) / main laboratory
- Sample reception and control, incl. Check of the temperature logger and related GMP Documentation
- Sample preparation (sorting, labeling)
- Sample distribution to the internal partners, shipping to the external partners
- Support the storage of stability samples
- Login samples (polled bulk) and document the chain of custody within the LIMS System
- Review and ensure the GMP documentation according to ALCOA principles (data integrity), Incl. planned and unplanned events (UPE and PE).
- Collaboration/creation of task-related documents (e.g. SOPs)
- Proposal/implementation of process improvements and harmonization
- Support the other flex team members of the section
- Support for inspections and audits ( incl. preparation)
- Support/collaboration in task-related and relevant projects (continuous improvement, IT and CSV etc)
- Critical assessment of your own work results to improve continuously

**Must Haves**:

- Vocational training in laboratory, logistic, production or similar with relevant professional experience
- At least 2 years of professional experience in the Pharmaceutical Industry, within a GMP environment and with SOPs
- Good computer skills and familiarity with databases, and GMP systems (knowledge of SingleLIMS, Phoenix and Veeva is an advantage)
- Very good knowledge of spoken and written German and good knowledge of English
- Very high teamwork and excellent communication skills
- Very high customer orientation, building and taking care of good relationships with internal and external partners
- Very high flexibility and organizational talent, high commitment,
- solution-oriented, able to work independently
- High reliability, quality and safety awareness
- Passion for continuous improvement activities

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