QA Manager (Operations, Compliance and Regulatory) / Qualified Person

  • Warszawa
  • Servier
.Reporting directly to the Quality Director, the person employed in this position will be responsible for: supervising, planning and organizing the work of the subordinate team, ensuring compliance of the Quality Management System with internal and external standards, implementation of new legal requirements and good practices, ensuring the preparation, organization and leading Authorities inspections, corporate audits and client audits constructing and supervising the implementation of the procedures of the Pharmaceutical Quality System responsibility for processes m.in. risk analysis, change control, corrective and preventive actions CAPA, cross-contamination prevention program, complaints, trainings, internal and external audits, product quality review and management review, supplier qualification, documentation system, data integrity and IT systems, quality agreements, compliance with registration dossiers taking independent decisions on batch certification and release or rejection of batches of medicinal products, making decisions on the suspension/withdrawal of a batch of a medicinal product from the market and coordinating and recording the withdrawal of a batch of a medicinal product from the market We are looking for candidates with: higher education: pharmacy, chemistry, biotechnology or related, at least 5 years of experience in a similar position, knowledge of Pharmaceutical Law and GMP requirements, ability to identify risk factors and develop risk analysis, ability to use MS Office, statistical tools, knowledge of ERP systems, very good level of written and spoken English The candidate should be characterized by: highly developed communication skills and the ability to work in and motivate a team ability to manage a team, delegate tasks, recruit and develop employees knowledge of the industry and market trends to adapt quality strategies to changing market requirements the ability to analyze data and processes, the ability to conduct risk assessments and implement preventive actions, the ability to manage change and improve processes resistance to stress and the ability to introduce changes with a focus on achieving targets, the ability to think analytically and critically and make decisions quickly, the ability to solve problems quickly and effectively, autonomy and innovation in action as well as openness to new challenges, commitment and motivation reliability and consistency in the performance of entrusted tasks. We offer: work in a stable and dynamically developing international company work culture based on the values of a reputable, international company, a contract for an indefinite period of time, attractive salary with a social package, interesting challenges and the opportunity for comprehensive professional development. Niezależnie od obszaru specjalizacji, Twoja praca w Grupie Servier przyczyni się do postępu terapeutycznego z korzyścią dla pacjentów. Dołączysz do wysoko wykwalifikowanego zespołu i w pełni rozwiniesz swój potencjał w profesjonalnym środowisku. Indywidualnie dostosowany proces onboardingu, możliwości mobilności wewnętrznej w ramach Grupy Servier, wysokiej jakości szkolenia, odpowiedzialne zarządzanie, kultura pracy zespołowej... Wszystko to i o wiele więcej w miejscu pracy, w którym Twoje samopoczucie jest dla nas ważne. W Servier współtworzymy postęp w medycynie w odpowiedzi na potrzeby pacjentów a różnorodność naszych pracowników uznajemy za źródło bogactwa sprzyjające realizacji naszego Powołania.