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At this position you will manage the team in the Quality Operations Department. You will be tasked with motivating employees and supporting them with substantive knowledge and expertise in the field of regulatory provisions. You will assist Quality Operations Head in developing, implementation and supervising the operation of the Quality Management System in the Quality Operations Department. Last but not least you will participate in the preparation of Polpharma Biologics S.A. for pharmaceutical inspections and audits carried out by domestic and foreign regulatory authorities by ensuring the correct conduct of processes for which the Quality Operations Department is responsible, including the batch documentation assessment process.
- Supervision over the proper preparation of the required GMP documents and their review
- Assessment and approval of the Quality Management System documentation prepared by Polpharma Biologics or prepared by contractors and/or external companies
- Development and updating of system documentation
- Approval of documentation related to the process and product (protocols, reports, etc.)
- Verification of compliance of the GMP documentation in the unit with internal and external regulations before its implementation
- Maintaining and developing the quality system in consultation with the Managing Quality Compliance and Operational Quality Compliance Departments
- Verification of production processes for compliance with GMP requirements through regular visits in the production area
- Review and approval reported deviations, OOX and complaints in accordance with the procedures in force, according to legal requirements
- Conducting and/or participating in internal and external audits
- Participation in change control processes, ensuring that the proposed changes comply with GMP requirements and that the management of changes is carried out in accordance with the internal procedures of Polpharma Biologics
- Participation in risk analysis and deviation management processes, including investigation, in compliance with internal procedures of Polpharma Biologics
- Fulfillment of duties in accordance with current GMP regulation and other pharmaceutical guidelines
- Fulfilling tasks assigned by the supervisor
- Supervision and active participation in solving quality problems and preventing their occurrence
- Participation in organization, implementation, systematic assessment of effectiveness and improvement of the quality system in accordance with current legal requirements, including GxP requirements, in the scope covered by the medicinal products and imported medicinal products license
- Informing the supervisor about qualitative problems, negative trends, audit observations, especially if they may affect patient safety, quality and efficacy of medicinal products
- Project management in terms of responsibilities
- Participating in processes related to the recall and/or withdrawal of the medicinal product or the investigational medicinal product from the market
- Participates in the preparation for audits and inspections in Polpharma Biologics
- Conducting internal training in scope of quality assurance and GxP for company employees at all levels of management
- Development and supervision of the proper use of the budget and human resources in the subordinate team
- Directing and providing support to subordinate employees and ensuring conditions enabling them to improve their qualifications and proper performance of duties
- University degree in biology, chemistry, pharmacy, biotechnology or related
- 5 years of working experience in the pharmaceutical industry, including 2 years in the evaluation of pharmaceutical products in the area of control or quality assurance as well as in team management
- Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment
- Knowledge of Quality Management Systems
- Fluent English
- Ability to work with MS Office
- Ability to make decisions
- Ability to work as a part of a team as well as being a leader
- Knowledge of the manufacturing technology of pharmaceutical products and analytical methods related to their assessment
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Polpharma Biologics
#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.