Beschreibung
Our client is an pharmaceutical world leader with a good work environment located in Bern. The job is an temporary contract where you can bring your expertise and with good salary.Missions
- Preparation, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment) focus on, but not limited to, CSV for new systems in collaboration with internal and external partner·
- Support for Change Control creation and tracking of defined action items · Contribution to ensure that changes to systems, procedures, processes and formulas are appropriately managed such that resulting impact on equipment / computerized systems commissioning and qualification process are assessed and resolved.
- Compilation of costs for CAPEX application (supplier quotations, and internal workload estimation)
- Management of all orders related to a project (delivery, delays, receipt, feedback)
- Organization of meetings and status reporting
Your profile
Bachelor/Master's degree in technical or natural sciences · A minimum of 3 years of working experience · Experience in the pharmaceutical industry and GMP · Know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines · Technical understanding of the function of equipment and understanding of the offers and needs of the departments (Qualification, Engineering, Production) · Sound experience with various IT-tools, systems, especially MS · Excellent communication skills · Business fluency in German and English · Understanding of automation related topics is a plus · Understanding of finance and cost control is a plus.
If you are interested in this opportunity, please send your application with your CV in Word format.
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.