Validation Expert- CSV, laboratory equipment, 6 months contract
We have an opportunity for an experienced validation expert for initial 6 months contract , to be based in Switzerland and support validation and qualification of new lab equipment and systems.
Involvement in the selection of suppliers, type and design of new lab equipment/systems
Provide input for the setup of the lab equipment validation plan (VMP) (Inventory, qualification status and additional information as required)
Creation of qualification documentation in collaboration with the laboratory and vendor (URS, IQ/OQ/PQ Protocol).
Set up of work instructions and SOP’s for the lab instrument in collaboration with the laboratory.
Organizing of set up of instrument PC, server environment, installation and configuration of application software in collaboration with the laboratory, vendor and IT.
Performing of IQ/OQ/PQ in collaboration with the laboratory and vendor.
Performing of software validation (e.g. ensure Annex11/Part11 compliance, user account check, audit trail functionalities, ensure backup and recovery of raw data).
Execution and follow up of periodic qualification and calibration activities for operational lab equipment/systems in cooperation with the technique responsible
A minimum of a Bachelor’s degree in Engineering or Chemistry or related technical or scientific discipline
Very good written and oral presentation skills
Working knowledge of GMPs,
Theoretical and practical knowledge of equipment used in a pharmaceutical environment is required. This includes simple equipment, but also automated integrated systems.
Knowledge of current qualification and validation methodology and its application within the pharmaceutical industry
Working knowledge of Quality systems
Strong knowledge and skills in MS Office
Fluent in German and English language
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.