Lab Equipment Qualification in Schaffhausen
Crystal Spilsbury at CK QLS is recruiting for a Laboratory Equipment Qualification Specialist to join a company in the Medical Device industry at their site based in Schaffhausen on a contract basis.
Our client is a global leader in the Medical Device sector and are looking for someone to join their team in Schaffhausen.
Your main duties will be:
- 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.
Further responsibilities will include:
- 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).
The ideal candidate for this role will have:
- A minimum of a Bachelor's degree in Engineering or Chemistry or related technical or scientific discipline.
- Working knowledge of GMPs.
- Theoretical and practical knowledge of equipment used in a pharmaceutical environment is required (simple equipment and automated integrated systems).
- Knowledge of current qualification and validation methodology and its application within the pharmaceutical industry.
- Working knowledge and skills of Quality systems and MS Office.Please note fluency in German and English is required for this role.
For more information or to apply for this position, please contact Crystal Spilsbury on +44 1438 905 156 or email cspilsbury@ckqls.ch. Please quote the reference QLS43341 in any correspondence.