Profession pharmaceutical quality specialist

Pharmaceutical quality specialists perform inspections and precision measurements in order to test and ensure the quality of pharmaceutical products. They are involved in the whole development phase of a pharmaceutical product until it is ready for the market. This includes the process of acquiring clinical trial licences, advising the pharmaceutical development staff on regulatory requirements and evaluating the content of the package leaflet and other documentation on the product. Moreover, pharmaceutical quality specialists collect and evaluate information on side effects of the product and communicate this knowledge both internally and to the relevant authorities.

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Personality Type

Knowledge

  • Pharmaceutical products

    The offered pharmaceutical products, their functionalities, properties and legal and regulatory requirements.

  • Analytical chemistry

    Instruments and methods used to separate, identify and quanitfy matter - the chemical components of natural and artificial materials and solutions.

  • Pharmaceutical legislation

    European and national legal framework for the development, distribution, and use of medicinal products for humans.

  • Laboratory techniques

    Techniques applied in the different fields of natural science in order to obtain experimental data such as gravimetric analysis, gas chromatography, electronic or thermic methods.

  • Pharmaceutical chemistry

    The chemical aspects of identification and synthetic alteration of chemical entities as they relate to therapeutic use. The way various chemicals affect biological systems and how they can be integrated in drug development.

  • Pharmaceutical technology

    Pharmaceutical technology is the branch of pharmaceutics which deals with the technological design, development, manufacture, and evaluation of drugs and medicinal products.

  • Controlled substances permits

    The legal requirements and licenses required when handling controlled substances.

  • Pharmaceutical industry

    The main stakeholders, companies and procedures in the pharmaceutical industry and the laws and regulations that govern the patenting, testing, safety and marketing of drugs.

  • Biotechnology

    The technology that uses, modifies or harnesses biological systems, organisms and cellular components to develop new technologies and products for specific uses.

Skills

  • Monitor manufacturing quality standards

    Monitor quality standards in manufacturing and finishing process.

  • Perform product testing

    Test processed workpieces or products for basic faults.

  • Work analytically

    Analyse information flows to reconstruct messages quickly and precisely. Navigate a language to explain the same sense or feeling in situations where there is no definite word or literal translation.

  • Work safely with chemicals

    Take the necessary precautions for storing, using and disposing chemical products.

Optional knowledge and skills

transfer chemicals perform chemical experiments chemical processes chemical products record data from biomedical tests record test data pharmacology basic chemicals

Source: Sisyphus ODB