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Polpharma Biologics S.A.

Physicochemical Quality Control Specialist

Polpharma Biologics S.A.O firmie

Polpharma Biologics S.A.

Trzy Lipy 3

Gdańsk

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!

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

We offer

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • And much more…

Why you should work with us

Contact us

[email protected]

grafika dolna

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!
Physicochemical Quality Control Specialist

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

We offer

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • And much more…

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.

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