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Management of the DP1, Quality Control and Supply Chain (Shared Support) supporting team in the Quality Operations Department. Motivating employees and supporting them with substantive knowledge and expertise in the field of regulatory provisions. To assist Quality Operations Head in developing, implementing and supervising the operation of the Quality Management System in the Quality Operations Department. Participation in the preparation of Polpharma Biologics S.A. for pharmaceutical inspections and audits carried out by domestic and foreign regulatory authorities. 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 S.A. 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.) for Polpharma Biologics S.A.
- 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.
- Approval of validation documentation for analytical methods, acceptance of transfer documentation regarding analytical methods.
- 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 S.A.
- Participation in risk analysis and deviation management processes, including investigation, in compliance with internal procedures of Polpharma Biologics S.A.
- Fulfillment of duties in accordance with current GMP regulation and other pharmaceutical guidelines.
- Ensure timely preparation of data required to prepare monthly / quarterly / annual quality system reviews.
- Comprehensive supervision over the storage process both at Polpharma Biologics and during storage at third parties.
- Participation in the complaint process to suppliers of materials / services.
- Complaint process to suppliers of materials / services management.
- Fulfilling tasks assigned by the supervisor.
- Supervision and active participation and substantive assistance 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, and especially when 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 and 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.4
- Higher education in biologics, chemistry, pharmacy, biotechnology or related, supported by min. 5 years of work experience in the pharmaceutical industry, including aseptic filling and two 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 knowledge of Polish both, written and spoken, fluent knowledge of English both, written and spoken.
- 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 technology of manufacturing pharmaceutical products and analytical methods related to their assessment.
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