#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
The Validation Manager is responsible for developing, implementing and managing the site validation strategies to meet cGMP and quality requirements on time and on budget to ensure that all equipment is compliant with Regulatory Authorities’ expectations and related SOPs.
- Developing and implementing Validation Master Plan for the whole factory.
- Driving establishment, prioritization, execution and tracking of all validation activities
- Establishing and monitoring validation KPIs.
- Maintaining all validation activities in an inspection ready status.
- Managing qualifications of equipment, utilities and rooms
- Authoring revalidation protocols and documentation.
- Ensuring all acitivities are conducted within agreed budget
- Min 5 years’ experience in defining and implementing requalification plans
- At least 5 years’ experience in validation ideally within the biotech or pharmaceutical industry.
- Good GMP and other pharmaceutical and biotechnological regulation knowledge
- Knowledge about method used in qualification of clean room systems and production equipment
- Experience with audits (GIF, FDA)
- University degree
- Good English
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Aleksandra Bufnal
aleksandra.bufnal@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.