Laboratory Equipment Qualification Specialist
A globally renowned pharmaceutical company is seeking to recruit a Laboratory Equipment Qualification Specialist to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.
- Becoming involved in the selection and justification of supplier, type, and design of new lab equipment/systems.
- Providing input for the setup of the lab equipment validation plan (VMP) (Inventory, qualification status, and additional information as required).
- Creating qualification documentation in collaboration with the laboratory and vendor (URS, IQ/OQ/PQ Protocol).
- Setting up work instructions and SOPs for the lab instrument in collaboration with the laboratory.
- Organizing and setting up instrument PC, server environment, installation, and configuration of application software in collaboration with the laboratory, vendor, and IT.
- Performing IQ/OQ/PQ in collaboration with the laboratory and vendor.
- Performing software validation (e.g. ensure Annex11/Part11 compliance, user account check, audit trail functionalities, ensure backup and recovery of raw data).
- Executing and following up on periodic qualification and calibration activities for operational lab equipment/systems in cooperation with the technique responsible.
Skills and Requirements:
- A minimum of a Bachelor's degree in Engineering, Chemistry, or related technical or scientific discipline.
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.