QA Specialist (m/f)

REFERENZNUMMER:

340726/11

IHRE AUFGABEN:

-Quality assurance services for Technical Operations Solids CH (including the WST-222)
-Support the microbiological qualification/validation of utilities, clean rooms and equipments (this activity includes the elaboration of qualification/validation protocols and reports and it comprises trouble shooting in the case of deviations.
-Operate as a microbiological SPOC for all microbiological related activities within the WST-222)
-Support the setup and later the microbiological monitoring of the environment in non-sterile production facilities (air and surfaces) including detergents and disinfectants in time and in accordance to cGMP rules, QMs and SOPs (this task includes the planning of activities, the evaluation and the interpretation as well as the documentation and the reporting of findings; furthermore, it comprises the correct investigation and documentation of deviations as well as the training of production personnel with regard to hygiene)
-Support the Decision making on “critical” and “non-critical” microbiological deviations and approval of the respective microbiological risk assessments
-Cooperation with PUs or other QA and QC teams in order to optimize the quality of the processes and the manufactured products as well as to maintain compliance with authority requirements
-Support preparation of authority inspections and participation as a microbiological expert
-Support authoring and reviewing of SOPs, either microbiological QA/QC-SOPs or production-SOPs
-Training of microbiological analyst and production operators after microbiological deviations or as regular training
-Supervision of the adherence to the safety and ecology guidelines

IHRE QUALIFIKATIONEN:

-University/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent
-Biological/microbiological analytics or diagnostics including growth properties of micro-organisms and culture media preparation
-Quality control/ assurance in pharmaceutical industry or biotechnology, especially with regard to environmental monitoring and cleanliness zones
-Fluency in German and English

WEITERE QUALIFIKATIONEN:

Quality manager