Laboratory Equipment Qualification Specialist
Posted on Nov 25, 2019 by Michael Bailey Associates - UK Contracts
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.