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Participate in Quality Management System (QMS) building in Technical and Development Department (TR&D) in Duchnice site. Ensure that procedures prepared on site are aligned with TR&D Quality Module, relevant requirements defined in Polpharma Biologics as well as EMA, FDA and other relevant guidelines. Monitor the QMS implementation in TR&D Duchnice by on-site quality audits and trainings. Perform and advise TR&D on risk assessments.
- Implementation and monitoring of the quality system in the TR&D Department
- Support in preparation of the TR&D area for inspections and audits, participation in the audits/ inspections and support of follow-up activities
- Verification of documentation in TR&D areas in terms of compliance with the applicable internal procedures and current regulations
- Contact with the TR&D Department of Polpharma Biologics to adapt the procedures and quality requirements to the standards of Polpharma Biologics
- Verification and approval of quality documentation in the area of Research and Technical Development
- Expert support in the assessment of process development project documentation; verification and approval of project documentation in the areas of USP and DSP process development
- Implementation of new guidelines, good practices and solutions improving data integrity in the area of TR&D
- Maintaining an internal control program
- Carrying out explanatory activities, root cause analysis and CAPA in the case of incidents and qualitative deviations in the area of TR&D
- Organizing and conducting quality training for the TR&D area
- Revision of the audit trails from process and analytical laboratory equipment to ensure data integrity is maintained within computerized systems, actions adjusted to the stage of development
- Master’s or PhD degree in a relevant field (pharmacy, biotechnology, biochemistry, chemistry)
- Very good knowledge of spoken and written English
- Knowledge of issues related to the pharmaceutical quality system
- Knowledge of MS Office
- Experience in working in an analytical, biotechnological and / or quality control laboratory in biotechnology or pharmaceutical companies
- Knowledge of data integrity
- Good organization of work and time
- Ability to cooperate with others to solve problems
- A minimum 2 year of experience in a similar position within Technical Research and Development, Quality Control, Quality Assurance or GMP regulated industry
- A minimum 3 years of experience within the biotechnological manufacturing/research
- Knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals
- Knowledge of Quality Management Systems
- Knowledge of Quality Risk Management/ risk based approach
- Problem-solving orientation
- Knowledge in the concept of the data traceability and integrity
- Experience with computer systems validations and laboratory equipment qualification will be an advantage
- Knowledge of regulations and guidelines contained in the ICH, FDA, EMEA and national guidelines
- Strong verbal and written communication skills (including Polish and English languages), good time management skills
- Ability to work with MS Office
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Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.