Qualification & Validation Consultant

vor 1 Monat


Frankfurt, Deutschland ARCONDIS Vollzeit

Tasks and responsibilities

Qualification of Equipment, instruments and facilities

Preparation of qualification and validation plans for laboratory and production-related processes

Preparation and review of specifications and risk analyses

Planning and witness SAT, FAT

Planning and execution of IQ-OQ-PQ

Processing of changes and deviations

Creation of Standard Operating Procedures (SOPs)

GMP-compliant documentation

Maintenance and archiving of documents

Ensuring training standards

Support of pharmaceutical release laboratories in GMP activities

Support in business development

Studies

Your profile

Successfully completed scientific or technical studies (for example: Pharmacy, MedTech, Biotechnology, Engineering, Chemistry) or technical apprenticeship

Practical experience in a pharmaceutical laboratory, MedTech or production environment

Very good GMP knowledge and in-depth knowledge of other regulatory requirements

Practical experience in quality assurance

Professional experience in qualification of laboratory equipment and facilities is an advantage

Experience in method validation of analytical methods is an advantage

Experience in LIMS or MES environment is an advantage

Careful, self-contained, and responsible way of working

Very good German and good English language skills as well as strong experience in working with computer systems

High degree of quality awareness, strong communication skills and the ability to work in interdisciplinary teams

Willingness to travel



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