Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.
Plan experimental work by ensuring availability of all resources including: materials, methods, equipment, human resources and functional facility; Lead execution of experimental work by working with junior scientists and technicians and providing clear guidance; Liaise with internal process...
Review the specialist literature in order to select the appropriate analytical control methods for new substances and biotechnology drug form; Independently conduct and later analyze and interpret the results of the research related to the development of new/modification of existing analytical...
Carry-out and monitoring of biotechnological production processes according to technological documentation, GMP rules and internal quality requirements; Analysis of achieved process data according to compliance with technological documentation and internal requirements; Participation in technology...
Carry-out and monitoring of biotechnological production processes according to technological documentation, GMP rules and internal quality requirements; Analysis of achieved process data according to compliance with technological documentation and internal requirements; Participation in technology...
Support process transfers and validation activities on production scale; Support SAT activities and qualification activities; Assist with day-to-day efficient operation of Microbial Manufacturing Plant; Analyse production processes and schedules to identify opportunities for improving coordination...
Ensuring cGMP and regulatory compliance of operations leading to biological Drug Substance and Drug Product; Ensure that all aspects of the handling, manufacturing of biopharmaceutical products at the site comply with the requirements meet all relevant cGMP regulatory and legislative requirements....
POLPHARMA S.A.pomorskie, Starogard Gdański
praca stacjonarna
2635 dni
wykonywanie badań analitycznych w oparciu o normy, specyfikacje, farmakopee; rejestracja próbek dostarczanych do badań i archiwum; prowadzenie dokumentacji analitycznej;
Manage the Quality Control Microbiology team; Perform all duties according to current GMP regulations and other pharmaceutical regulations. Prepare and review the microbial method validation, qualification of equipment; Prepare and review the protocols, reports, procedures and all required...
Generate robust tech transfer plans and protocols in close collaboration with biologics process & analytical development, manufacturing, QC/QA and, if applicable, external partners; Provide technical expertise on manufacturing processes during initial risk / gap assessments and make recommendations...
Establish the new microbial facility including chose of production line, participation in engineering activities, supervision of SAT,FAT, IQ/OQ and PQ activities compliant with GMP regulations; Supervise the technology transfer of internally developed products and for CMO purpose; Build, lead,...
Planning of experiments; Execution of experiments without supervision; Storing and managing data according to GDevP and internal procedures; Collaboration with other departments (USP, DSP, ADS, QC, QA, PP) Collaboration with IP department on formulation patent searches; Mentoring junior staff...
Preparation of qualification documentation: qualification plans, protocols and reports; Conducting the qualification tests related to Production/Process Equipment or Quality Control Equipment; Initiating and leading the Risk Assessments; Monitoring and supervision of system documentation related to...
Supervision and coordination of the Documentation Team and ensuring quality compliance within the Technical Operations Department; Supervision of the aforementioned Department’s documentation, adaptation of procedures and system documentation to the user’s needs while meeting GMP requirements;...
Tworzeniem i wdrażaniem procedur, regulaminów oraz standardów postępowań w zakresie BHP i P.POŻ wynikających z rozporządzeń i innych aktów prawnych mających zastosowanie na danym stanowisku pracy; Doradztwem w zakresie BHP oraz P.POŻ; Przeprowadzaniem kontroli i audytów w zakresie BHP,...
opracowywanie, wdrożenie i zatwierdzanie dokumentacji systemowej i jakościowej zgodnie z przyjętym systemem oraz wymaganiami cGMP; opracowywanie dokumentacji i nadzór nad wyrobami medycznymi; przygotowywanie umów jakościowych; udział w procesach Kwalifikacji Dostawców; udział w procesach...
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