Physicochemical Quality Control Specialist
Gdańsk
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, as a member of our growing Quality Control Phys-Chem team, you will be responsible for conducting physico-chemical analyses of products and raw materials. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry.
Your responsibilities
- 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
- Participation in 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
- 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 pharmaceutical or biotech industry (at least 3 years)
- Experience in working with instrumental analytical techniques in the field of physicochemical tests of biotechnological drugs and/or raw materials, including such as: 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 (highly preferable)
- Minimum basic knowledge of statistical techniques
- Knowledge of MS Office pack
- Fluent English spoken and written
- Organizational and self solving problems skills
- Strong communication skills