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Laboratory Equipment Qualification Specialist

Eingestellt von Experis AG

Gesuchte Skills: Engineering, Client

Projektbeschreibung

Laboratory Equipment Qualification Specialist (German and English)

Experis IT is Europe's leading IT recruitment agency. With offices in Zurich, Basel, Geneva and Lausanne, we specialise in the Information Technology sector.

My client is one of the leading medical devices businesses in Switzerland and is looking for a Laboratory Equipment Qualification Specialist. This is a long-term contract in its Schaffhausen offices. My client is requesting a highly skilled individual who specializes in simple equipment and automated integrated systems.

If you are interested in the position, then please check the criteria below:

Start date: 01/10/2018

End date: 29/03/2019

Work location: Schaffhausen

Workload: 100%

Your tasks & responsibilities:

-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 (eg 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

What you must have:

* 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
. Team spirit, good communication and flexibility are required skills
. Fast learner, able to work independently, "can do" aptitude required
. Fluency in English and German

Interested in this opportunity? Kindly send us your CV today through the link in the advert.

However, should you have any questions please contact Virginia Belli or email

Projektdetails

  • Einsatzort:

    Schaffhausen, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    29/03/2019

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Experis AG