QC Physicochemical 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 responsibilities
- Participating in the project related to the launch of a new laboratory and other projects implemented in the Quality Control;
- Performing transfer and validation of physicochemical methods;
- Performing qualitative and quantitative physicochemical tests in tested products and starting materials;
- Verification of the correctness of test documentation in accordance with applicable procedures;
- Collection and registration of clean media, raw materials, semi-finished products, products ready for analytical testing;
- Participation in the development of the GMP system in the Quality Control Laboratory;
- Conducting investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality;
- Participation in the preparation of the Quality Control area for GMP audits and certification;
- Working out of standard procedures, instructions and analytical methods as well as training in them;
- Performing maintenance, calibration and qualification of laboratory equipment in accordance with applicable instructions and procedures.
If you have
- Higher education, with a specialization in the fields: chemistry, biotechnology, biochemistry or related,
- Experience of working in an analytical laboratory or quality control laboratory in a pharmaceutical or biotech works (at least 5 years),
- Experience in working with instrumental analytical techniques in the field of physicochemical tests of biotechnological drugs and raw materials: chromatography (HPLC, UPLC, GC), UV/VIS spectrophotometry, FT-IR, capillary electrophoresis,
- Practical and theoretical knowledge in the field of validation and transfer of analytical methods;
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines,
- Experience in testing of biotechnological products;
- Knowledge of MS Office;
- Very good English spoken and written;
- Organizational skills;
- Strong communication skills.