QC Equipment Management Senior Specialist
Duchnice
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
In this role you will be responsible for:
- implementation of tasks in the scope of management and administration of laboratory equipment;
- implementation of the work of the team in order to ensure the required level of service for other teams of the Quality Control Department;
- implementation of tasks related to the quality control projects.
Your responsibilities:
- Management and administration of laboratory equipment and related computer systems (e.g. Empower, Tiamo);
- Supervision of timeliness and correctness of lab device’s maintenance, repair and qualification activities (both carried out internally and by external services);
- Participation in developing or reviewing quality system documentation;
- Responsibility for maintaining the costs level defined in the approved annual budget;
- Participation in lab investigations and associated corrective and preventive actions;
- Participation in the change control process;
- Participation in internal and external audits and implementation of post-audit recommendations;
- Designing and supporting implementation of continuous improvement initiatives.
If you have:
- Higher directional education;
- More than 5 years of professional experience;
- Knowledge of EMA guidelines, pharmacopoeia monographs, GMP regulations and pharmaceutical laws;
- Ability to communicate effectively internally within QC and external teams;
- Ability to set priorities and multi-task;
- Ability to clearly report and present results;
- Familiarity with analytical techniques and associated instrumentation;
- Basic knowledge of statistical analyses;
- Fluency in spoken and written English;
- Knowledge of MS Office.
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.