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Laboratory Equipment Qualification Specialist

Posted on Nov 25, 2019 by Michael Bailey Associates - UK Contracts

Not Specified, Switzerland
Research
2 Dec 2019
Annual Salary
Contract/Project

POSITION DUTIES & 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

PROFESSIONAL EXPERIENCE REQUIREMENTS:

  • A minimum of a Bachelor's degree in Engineering or Chemistry or related technical or scientific discipline
  • Very good written and oral presentation skills (English)
  • 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

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 802587204

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