Stein is a site of strategic importance for the manufacturing and launch of innovative medicine. One of the most important pharmaceutical production plants of Novartis Technical Operations is located in Stein : The plant Stein Steriles.
The plant is launch site & center of excellence worldwide for innovative sterile drug products for injection containing Biologics as well as manufacturing site for clinical supplies of all sterile dosage forms required in global clinical studies.
The AS&T Specialist overviews all activities concerning stabilities of the assigned Biotech drug products. He / she designs, interprets and reports stability studies and ensures the compliant, efficient and timely handling and management of stability samples.
The main responsibilities are :
Ensures that all sample logistics are performed and documented accordingly
Manages the administration of stability programs, taking into consideration regulatory stability requirements and information of the approved stability protocols
Ensures samples are taken according to the relevant stability program, that samples are stored in the stability chambers promptly upon receipt and all samples and associated documentation are available the laboratories within the required timelines
Provides expert advice on all stability related topics, such as deviations
Timely prepares and reviews stability protocols and reports, taking into account current regulatory requirements, requests from Health Authorities and general guidelines
Supports preparation for internal and external inspections answers questions during inspections. Ensures implementation of associated corrective and preventive actions
University degree in pharmacy, chemistry or equivalent
Several years of relevant work experience in a quality role on a pharmaceutical manufacturing site
Good knowledge of stability guidelines (ICH Q1, etc.)
Fluent in German and English (spoken / written)