USP Specialist
Duchnice
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!
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.