Praca: USP Specialist

USP Specialist
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities
  • Elaboration, verification design and qualification documentation. Participation during equipment and systems qualification.
  • Elaboration of SOPs and manuals (including manuals to equipment).
  • Documentation preparation according GMP rules and internal company requirements.
  • Attending during technology transfer, process validation in cooperation with Research and Development Department/ Client.
  • Running and monitoring the manufacturing process of biotechnology product according to GMP requirements, technological documentation and other internal requirements.
  • Supporting of production team in aim of effective resources utilization, conducting the trainings.
  • Actual delivering supervisor or proper people reports and all necessary documentation to process evaluation.
  • Informing direct supervisor about all abnormalities in process, documentation, progress of tasks and decisions.
  • Report preparation of performed tasks.
  • Keeping documentation in accordance with the requirements of GMP.
  • Preparation and updating of system documents, procedures and instructions as well as related documentation in accordance with the GMP requirements.
  • Running the training for employees of the Production Department.
  • Close cooperation with the Quality Department.
  • Participating in audits of suppliers of services and materials related to the production.
  • Cooperation with all Production Department team and other groups from site and Polpharma Biologics.
If you have
  • Higher education (at least Msc) in Biotechnology, Pharmacy or similar.
  • At least one year experience in biotechnological or pharmaceutical industry.
  • Good knowledge of cGMP and FDA requirements.
  • Experience in work with recombinant proteins and their purification. Performing monoclonal antibody purification process in production scale according to GMP rules.
  • Good knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production.
  • Good work organization, individual problem solving, good communication, team cooperation skills and being open for new tasks are required.
  • Very good speaking and writing English skills (level B2).
  • Knowledge of MS Office.
Join our Team!
Why you should work with us
Contact us