QC Microbiology Senior Specialist

As a part of our dynamic Quality Control team, you will take care of a broad scope of responsibilities within the highly regulated, but very dynamic laboratory environment. You will also serve as a mentor for more junior team members. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry.

• Building of a pharmaceutical quality assurance system, qualification of control and measurement equipment, preparation for GMP certification - applicable to the design phase.
• Timeliness of analytical work related to the validation of the product manufacturing process/active substance and the transfer of methods and the qualification of microbiological methods.
• Conducting investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality.
• Participation in developing or giving opinions on Instructions and Procedures, including the Operating Instructions for control and measurement equipment.
• Participating in change control processes (eg. by issuing opinions on new tests methods and specifications and their implementation in the team).
• Performing research in the field of microbiological monitoring of the production environment in accordance with GMP requirements and the plans and schedules of these tests.
• Performing microbiological diagnostics.
• Work with microorganisms

• Higher Education microbial biotechnology, pharmaceutical or similar.
• Well-established analytical and microbiological knowledge
• Knowledge of EMA, FDA requirements, pharmacopeial monographs, GMP regulations and pharmaceutical law issues.
• Basic knowledge regarding the principles of microbiological environmental monitoring
• Knowledge of working with microorganisms, chemical, reagents, disinfectants
• Computer skills and knowledge of MS Office