#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 position you will take part in preparations for audits and inspections. You will work with Quality documentation and you will be responsible for reporting on quality standards, deviations and CAPAs.
- Improvement activities to continuously improve effectiveness and compliance in Quality Control
- Reviewing quality records of Quality Control to ensure completeness and adequacy
- Implementing new GMP regulations and compile or update SOPs defining these regulations
- Investigations related to deviations, corrective and preventive actions implementation and change control management
- Preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by national and international regulatory bodies
- Performing regular compliance checks in Quality Control
- Ensuring that all corrective actions after internal and external audits are effective and verified
- Monitoring of internal audit non-conformances, performing trend analyses, and monitoring of current findings
- Contact and cooperation with domestic and foreign regulatory authorities
- University degree (Biology, Chemistry, Pharmacy, Biotechnology or similar)
- Min. 5 years of working experience in pharmaceutical industry, including min. 2 years of laboratory experience (in GLP/GMP environment)
- Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, biopharmaceuticals specifically
- Understanding of analytical technologies related to the evaluation of pharmaceutical products
- Knowledge of Quality Management Systems, with specific understanding in managing deviations, investigations and corrective/preventing actions as a main tool in the areas
- Decision making ability
- Teamwork ability
- Ability to interpret and apply domestic and international regulations
- Very good command of English, written and spoken
- 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.