Beschreibung
Are you an experienced Laboratory Equipment Qualification Specialist (m/f) looking for a new project? Our client, a large/small/renown pharmaceuticals company with locations and laboratories various countries offers an interesting and exciting opportunity for freelance Laboratory Equipment Qualification Specialist (m/f).Your role as Laboratory Equipment Qualification Specialist (m/f)
- Involvement in the selection and justification of supplier, 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
Required skills
- 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
Further information
- location: Border region to Germany
- start date: 01.10.2018
- duration: 6 months
Interested?
If you would like to apply for this pharmaceutical project as Laboratory Equipment Qualification Specialist (m/f), please contact me via phone for more information. Or send me an mail with your updated CV
We are looking forward to your application.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.