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.