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Stability and Sample Manager

vor 3 Wochen

Basel, Schweiz ITech Consult Vollzeit

**Stability and Sample Manager (M/F/d) - LIMS / GMP / German / English / Documentation**

**Project**:
For our client, a large pharmaceutical company based in Basel, we are looking for a **Stability and Sample Manager (M/F/d)**

**Background**:
We work with passion to improve the health and lives of patients. We show courage in our decisions and actions. And we are convinced that good and successful actions contribute to a better world.
That is why we come to work every day. We are committed to science, to adhering to the highest ethical standards and to creating access to medical innovations for all. We do this to contribute to a better future.
At the Basel site, the Synthetic Molecules Technical Development (PTDC) department is responsible for the technical development of our pipeline of active substances (DS) and drugs (DP) for clinical trials.
The Lab Support and Compliance section is part of the “Operations Support & Compliance” (OSC) department within “Synthetic Molecules Technical Development” (PTDC) at the Basel site. The OSC department 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 stability studies management of DS and DP and sample management.

**Main tasks and areas of responsibility**:

- Main tasks are in the area of Stability and Samples Management (development)
- Support in the recording and implementation of current activities such as Stability Management DS and non-GMP stability of devices, including GMP documentation creation and process improvement.
- Storage/removal of stability samples according to stability studies using LIMS and clarifications with the relevant contact persons (e.g. project manager)
- Management and documentation of stability samples for NBEs and NCEs (New Biological or
Chemical Entities) Drug Product in accordance with applicable regulatory requirements and Roche internal requirements within Pharmaceutical Technical Development
- Preparation of stability studies based on the stability test plans submitted by the project managers and their maintenance in the LIMS system
- Review and ensuring up-to-date GMP documentation
- Collaboration/preparation of task-related documents (e.g. SOPs) and responsibility for their compliance
- Sample coordination, forwarding of samples to the relevant departments (internal Roche laboratories and external departments)
- Proposal/implementation of process improvements and harmonizations
- Representation and support of the other Flex Team members of the section
- Support with inspections and audits

**Must Haves**:

- Professional training in the scientific field, quality, laboratory, production or comparable with relevant professional experience
- Experience in the pharmaceutical sector, with at least 2 years in the GMP environment
- High quality and safety awareness
- Good IT knowledge and familiarity with databases, LIMS knowledge is an advantage
- Fluent written and spoken German and good English skills
- Very high ability to work in a team and communicate
- Very high customer orientation, building and maintaining relationships with internal and external partners
- Very high flexibility and organizational talent, high level of commitment, reliability and independence
- Passion for continuous improvement Activities

**Role**: Stability and Sample Manager (M/F/d)
**Industry**: Pharma
**Place of work**: Basel
**Workload: 100%**
**Duration: 12++**

**Job Type**: 100%

Work Location: On the road