Quality Control Specialist (Biological Group)
Place of work: Starogard Gdański
RESPONSIBILITIES:
- Conducting quality control of starting/raw materials, Biological Drug substance and Drug product.
- Conducting analytical method transfer to quality control and validation of analytical methods
- Analyzing and interpreting the results of tests carried out individually or by co-workers
- Keeping records of the carried out tests and validation of methods in accordance with existing standard operating procedures and the principles of GMP
- Preparing quality documentation required in the registration and implementation of new biotechnological drugs products
- Developing standard operating procedures and instructions and conducting the training on them
- Developing manuals of analytical equipment and other devices, conducting trainings on them
- Perform maintenance, calibration and qualification of equipment in accordance with the instructions and procedures
- Supervising the work of technicians and specialists in the assigned task. Indirect responsibility for assigned specialist, junior specialist and technicians
- Controlling the usage and preparation demands for direct and supporting materials as well as substances and reagents used during the research
- Evaluation of the documentation other companies concerning analytical methods and conducted tests
REQUIREMENTS:
- At least 3 years of experience in laboratory work (biotechnological or quality control laboratory)
- Higher education with a specialization in the fields: biotechnology, molecular biology, biochemistry, chemistry, pharmacy or related science based degree.
- Knowledge of biochemical techniques concerning work with DNA and therapeutic proteins and knowledge of bioanalytical methods based on the intrinsic properties of biomolecules and molecular recognition such as: electrophoresis techniques, PCR, immunochemical tests and other bio-specific tests (blotting, ELISA, SPR)
- Knowledge of analytical techniques such as: liquid chromatography, gas chromatography, UV/VIS, IR spectroscopy, MS would be an advantage
- Knowledge of issues related to cGMP and GLP and knowledge of current guidelines for characterization, testing and registration of biosimilars (ICH, EMA, FDA)
- Very good knowledge of spoken and written Polish and English
- Knowledge of MS Office
- Good problem solving skills and good organization of work and time
- Ability to cooperate with others
WE OFFER:
- Contributing to the success modern, rapidly growing pharmaceutical company
- Motivating salary appropriate for competence and performance
- Opportunity for professional development
- Necessary tools - computer, phone
- Comprehensive benefits package (including private medical care, group life insurance, meals subsidies)
Poznaj
POLPHARMA S.A.
Zdrowe jutro zaczyna się od ludzi, którzy tworzą Polpharmę – od ich wiedzy, zaangażowania i pasji. Wspólnie dbamy o zdrowie innych i tworzymy środowisko, w którym każdy może być sobą. Rozwijamy się w zgodzie z własnymi ambicjami, niezależnie od obszaru, w jakim działamy. Razem z nami możesz realnie wpływać na zdrowie i dobrostan innych.