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As a member of our Technical Operations department you will participate in technology transfer in accordance with cGMP and internal regulations during the implementation of projects related to the introduction of new biotechnology products. You will participate in manufacturing of biotechnology products in accordance with GMP principles and FDA requirements.
- 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;
- Participation in technology transfer and process validation in cooperation with MSAT and external Clients;
- Running and monitoring the manufacturing process of biotechnology production according to GMP requirements, technological documentation and other internal requirements;
- Coordination of production team in aim of effective resources utilization, conducting the trainings;
- Close cooperation with the MS&T, Production Operational Department and Quality Department;
- Supervision over schedules related to the preparation of GMP documentation in the Production Department - e.g. procedures, qualification documents, etc.
- Supervision and issuance of system documentation in the Production Department
- Monitoring the progress of preparation for inspections and audits (external and internal).
- Higher education in Biotechnology;
- Minimum 3 years of experience in biotechnological or pharmaceutical industry;
- Good knowledge of cGMP and FDA requirements;
- Experience with recombinant proteins in production scale;
- Experience with protein purification processes;
- Knowledge of filtration and chromatography techniques.
Poznaj
Polpharma Biologics
#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.