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 (e.g., 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.
#J-18808-Ljbffr