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)
Maintenance and archiving of documents
Ensuring training standards
Support of pharmaceutical release laboratories in GMP activities
Support in business development
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
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