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At this position you will be tasked with performing of physicochemical testing as well as taking care of proper documentation within GMP regulated environment. You will take part in transfers and validations of analytical methods, investigations, corrective and preventive actions.
- 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
- University degree 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 environment (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
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.