#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.
Your responsibilities: Plan, managed, support and implement the quality assurance of process, cleaning, transport and sanitization/sterilization validation program consisting of entire system lifecycle in order to ensure compliance with relevant regulatory requirements and industry guidelines....
Your responsibilities: Follow all Companies procedures and assure personal trainings are complete and up to date. Active participation in development of system requirements and specifications to ensure that the requirements are testable and that the relevant regulatory requirements are met; Review...
specjalista mid / senior / ekspert umowa o pracę pełny etat
732 dni
Your responsibilities: Authoring, reviewing and approving validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV; Initiating and performing the GxP risk and impact assessments; Taking part in CSV related Deviation, CAPA and change control...
If you have: University degree with specialization in Pharmacy, Biotechnology, Biology, Chemistry or related fields; Experience working in an analytical or quality control laboratory in pharmaceutical or biotechnological company (at least 3 years) Knowledge of Good Laboratory Practice (GLP) and Good...
kierownik/koordynator / menedżer umowa o pracę pełny etat
732 dni
Your responsibilities: Implement a phase appropriate Quality Management System for Technical Research and Development (TR&D) in Utrecht in close alignment with the Polpharma Biologics Group standards; Define and map quality processes for TR&D activities; Provide Quality Oversight for TR&D projects...
specjalista mid / senior / ekspert umowa o pracę pełny etat
732 dni
Your role Coordinate and lead activities related to DSP data analyzes related to the production of monoclonal antibodies at DSP stages as part of process transfer, process scaling, GMP production and process validation. Participation in the transfer of technology/process validation in accordance...
Your responsibilities: Acting on own initiative to deliver key assignments, and prioritizing work according to changing business situation; Maintaining complex and detailed calendars; Building effective working relationships with key stakeholders; Managing the coordination and logistics of both...
Your responsibilities: Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements; TrackWise system administration supporting day-to-day operations; Managing ongoing administration activities, such as: user access security, periodic system review...
specjalista (mid) / menedżer umowa o pracę pełny etat
732 dni
If you have: Experience in application support with strong IT basics, preferably in the pharmaceutical industry within GxP environment. Experience with SAP Solution Manager (Test Suite) and/or knowledge on the concept of Application Lifecycle Management (ALM) will be an advantage. Must be able to...
Your role: In this role you will plan, execute, interpret and document the experiments aimed at development of the fill and finish processes (including lyophilization) for final drug product. As an advantage you will also assist in troubleshooting at Drug Product Manufacturing. Your...
Twoja rola Udział w procesie wytwarzania produktów biotechnologicznych zgodnie z zasadami GMP oraz wymogami FDA w celu otrzymania produktu o jakości zadanej w specyfikacji. Udział w transferze technologii zgodnie z regulacjami cGMP oraz wewnętrznymi w trakcie realizacji projektów związanych z...
specjalista junior / mid / senior umowa o pracę pełny etat
754 dni
Twoje zadania: Wykonywaniem badań fizykochemicznych w oparciu o odpowiednią dokumentację w celu dostarczenia informacji o badanych produktach oraz materiałach wyjściowych; Planowaniem i wykonywaniem walidacji i transferu metod fizykochemicznych wraz z przygotowywaniem związanej z tym...
specjalista mid / senior / ekspert umowa o pracę pełny etat
754 dni
Your role: You will have the unique opportunity to participate in strengthening Quality Culture in the new biotechnological facility by partnering production, engineering, supply chain and quality control departments. You will be responsible for ensuring that GMP requirements are properly applied in...
specjalista mid / senior / ekspert umowa o pracę pełny etat
754 dni
Your role: You will have the unique opportunity to participate in strengthening Quality Culture in the new biotechnological facility by partnering production, engineering, supply chain and quality control departments. You will be responsible for ensuring that GxP requirements are met for IMP and...
Your responsibilities: Verify and process incoming invoices, including PO and non PO invoices, Perform regular analysis over supplier accounts, Your daily job will be to constantly search for further automation and standardization in the process, Ensure that all invoice are paid when due and verify...