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