#PolpharmaBiologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
In this role you will be responsible for reviews and updates of quality procedures, preparation of proper documentation and ensuring proper course of action in reference to investigations (deviations), corrective and preventive actions and change control management. You will cooperate with domestic and foreign regulatory authorities and participate in preparations of Polpharma Biologics to pharmaceutical inspections and audits.
- Creation and updates of quality procedures
- Supporting the process of creation, improvement, standardization of documentation and quality standards of QC at Polpharma Biologics
- Performing paper and electronic data review to ensure data integrity in the Quality Control
- Ensuring proper management, compliance and integrity of Quality Control documentation, such as SOPs, protocols, reports, results, methods, specifications etc.
- Supporting management of CAPA, deviations, change controls, OOS, risk analyses and ensuring if the closing process of quality records is consistent with procedures and deadlines
- Supporting owners of quality records in reference root cause analyses, investigations related to deviations, OOS researches, risk analyses, defining tasks in reference to Change Controls
- Ensure implementation of all corrective actions after internal and external audits
- Participation in processes improvements to increase their efficiency
- Performing all duties with respect to current GMP requirements and other pharmaceutical regulations
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or related) or 4 years of working experience in the pharmaceutical industry
- Minimum 5 years of experience in regulated laboratory environment (biotechnological lab will be an advantage)
- Very good knowledge of GMP and GDP (Good Documentation Practice) rules
- Ability to solve problems independently
- Teamwork ability
- Fluent English, written and spoken
- Good knowledge of MS Office
- Good organizational skills
- Prioritization skills, ability to work towards tight deadlines
- Analytical thinking ability
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
Poznaj
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.