Production Process Trainer
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 responsibilities
- Defining and developing training needs, conducting trainings in on-line form and stationary training regarding GMP rules for Production Department employees;
- Establishing and developing training documentation for Production Department employees. Maintaining the training documentation in accordance with GMP;
- Supporting assessment of employee readiness for independent work in manufacturing area;
- Elaboration of SOPs and instructions and training from them;
- Documentation preparation according GMP rules and internal company requirements.
- Monitoring the manufacturing process of biotechnology product accorrding to GMP requirements, technological documentation and other internal requirements.;
- Supporting of production team in aim of effective resources utilization, conducting the trainings;
- Conducting the training for employees of the Production Department in the scope of GMP, qualification activities and DI;
- Participation in investigation for quality deviations and implementation of CAPA.
If you have
- Higher education in Biotechnology, Biology, Chemistry or similar (life/natural sciences);
- Minimum 2 years of experience in a similar position;
- Good knowledge of EudraLex GMP and FDA requirements for biological and sterile products;
- Experience in working with recombinant proteins and their purification. Additional advantage will be performing monoclonal antibody purification process in production scale according to GMP rules;
- Experience in working with manufacturing documentation;
- Good knowledge of aseptic techniques and Single Use Technology used in biopharmaceutical production will be additional advantage;
- Very good speaking and writing English skills (level B2);
- Coaching competencies;
- Good work organization, problem solving, very good communication skills.