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

Opis stanowiska:

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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.