QC Physico-Chemical Senior Specialist

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. You will also serve as a mentor for more junior team members. This position is an opportunity for you to become a valuable expert in the biopharmaceutical industry.

• Participating in the project related to the launch of a new laboratory at the plant on biotechnology and other projects implemented in 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.

• 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 works, (at least 5 years);
• Experience in working with instrumental analytical techniques in the field of physicochemical tests of biotechnological drugs and 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;
• 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;