Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
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
Poznaj
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.