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.
