Polpharma Biologics is part of the Polpharma Group, one of the largest pharmaceutical companies in Central and Eastern Europe. We focus on the development and production of biological medicines. Our international team consist of experiences experts and young scientists. We share common goal - to improve the quality of patients' ;ife with more availabe biological medicines of the hishest quality.
Senior Qualification Specialist
Location: Gdańsk
If you want to work:
- in one of the most modern biotechnology centres in Europe
- in a place where professionals from all over the world work on the highest-quality equipment
- in the production of biotechnological drugs, which give access to effective therapy to more patiens
- in a company that will give you stable employment, competitive renumerations, attractive benefits and the opportunity to participate in trainings at home and abroad
Currently we’re looking for
1
Senior Qualification Specialist
Join “start-up” Biologics division with strong international and local team at site!
We are waiting just for you!
What will you do?
- Preparation of qualification documentation: qualification plans, protocols and reports
- Conducting the qualification tests related to Production/Process Equipment or Quality Control Equipment
- Initiating and leading the Risk Assessments
- Monitoring and supervision of system documentation related to qualification activities
- Conducting trainings on procedures for qualifying activities
- Conducting activities in accordance with the applicable cGMP, FDA and internal procedures
- Overseeing the qualification status of equipment and production installations
- Initiating corrective actions resulting from deviations identified during qualification activities
- Verification of the qualification documentation and comparison of the obtained results with the acceptance criterion
- Revising validation and qualification documentation of the Direct Impact Systems
What do we expect?
- Higher directional education (biotechnology, biology, pharmacy or technical related fields)
- Knowledge of the cGMP and FDA regulations
- Experience with production/ process or quality control equipment
- Experience in developing qualification documentation in accordance with GDP and GMP principles
- Experience in conducting qualifying activities on Risk Assessments, DQ, IQ, OQ and PQ
- Ability to recognize and solve problems independently, good organization skills, ability to work efficiently under time pressure
- Fluent English
- Flexibility, communication skills, teamwork spirit
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.