Qualification Specialist
Gdańsk
Replacement contract
Boost your career with us
Polpharma Biologics 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 medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role:
Execution of qualification proces of analytical equipment in the QC area, in accordance with cGMP requirements. Execution of assigned qualification tasks and supporting other Departments in qualification activities.
Your responsibilities:
- Performing initial qualification of Technical systems of Quality Control Department;
- Maintaining the qualification status of the Technical systems of Quality Control Department through cyclical qualification activities;
- Developing internal qualification documentation;
- Supervision over the external service that qualifies the Technical systems of the Quality Control Department;
- Documenting qualification activities on dedicated qualification protocols;
- Infroming the direct superior of any discrepancies found during qualification activities;
- Taking part in corrective and preventive actions resulting from discrepancies found during qualification activities;
- Participate in reviewing internal procedures for Technical systems qualification;
- Monitoring the status and timing of qualification activities for assigned Technical Systems.
If you have:
- Higher directional education (biotechnology, biology, pharmacy or related fields);
- Knowledge of cGMP and FDA requirements;
- Experience in developing validation documentation according to GDP and GMP principles;
- Experience in conducting qualification activities of analytical equipment according to USP 1058;
- Ability to recognize and solve problems on their own, good organization of time and work, ability to work efficiently under pressure of time and responsibilities;
- Good knowledge of written and oral English, knowledge of MS Office package;
- Flexibility for new tasks, communication skills, ability to work in a team.
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.