controlled substances permits
The legal requirements and licenses required when handling controlled substances.
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.
Competences and skills
34 ESCO relationsEssential knowledge 9 competences
Occupation specific
0 competencesNo competences in this bucket.
Sector-specific
2 competencespharmaceutical products
The offered pharmaceutical products, their functionalities, properties and legal and regulatory requirements.
Cross-sector
7 competencesanalytical chemistry
Instruments and methods used to separate, identify and quantify matter-the chemical components of natural and artificial materials and solutions.
biotechnology
The technology that uses, modifies or harnesses biological systems, organisms and cellular components to develop new technologies and products for specific uses.
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 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.
pharmaceutical legislation
European and national legal framework for the development, distribution, and use of medicinal products for humans.
pharmaceutical technology
Pharmaceutical technology is the branch of pharmaceutics which deals with the technological design, development, manufacture, and evaluation of drugs and medicinal products.
Essential skills and competences 11 competences
Occupation specific
0 competencesNo competences in this bucket.
Sector-specific
6 competencescomply with quality standards related to healthcare practice
Apply quality standards related to risk management, safety procedures, patients feedback, screening and medical devices in daily practice, as they are recognized by the national professional associations and authorities.
ensure pharmacovigilance
Report on the adverse reactions of pharmaceutical products to the competent authorities.
manage medication safety issues
Take action to prevent, minimise, resolve and follow-up medicines related problems, maintaining and contributing to a reporting system of pharmacovigilance.
test medicinal products
Test medicinal products and their effects and interactions in a laboratory.
test pharmaceutical process
Test the systems used to manufacture pharmaceuticals measuring and analysing the processes to ensure that the products are produced according to specifications.
work safely with chemicals
Take the necessary precautions for storing, using and disposing chemical products.
Cross-sector
5 competencesconduct quality control analysis
Conduct inspections and tests of services, processes, or products to evaluate quality.
ensure quality assurance for pharmaceutical products
Take the necessary steps to guarantee the quality of pharmaceutical products ensuring that the refrigerators/freezers are at the correct temperature and complete the appropriate documentation.
manufacture medicines
Formulate and compound medicines performing pharmaceutical calculations, selecting the appropriate route of administration and dosage form for the medicine, the appropriate ingredients and excipients of the required quality standard, and preparing pharmaceutical products.
monitor manufacturing quality standards
Monitor quality standards in manufacturing and finishing process.
perform product testing
Test processed workpieces or products for basic faults.
Optional knowledge 4 competences
Occupation specific
0 competencesNo competences in this bucket.
Sector-specific
2 competenceschemical processes
The relevant chemical processes used in manufacture, such as purification, seperation, emulgation and dispergation processing.
chemical products
The offered chemical products, their functionalities, properties and legal and regulatory requirements.
Cross-sector
2 competencesbasic chemicals
The production and characteristisc of organic basic chemicals such as ethanol, methanol, benzene and inorganic basic chemicals such as oxygen, nitrogen, hydrogen.
pharmacology
Pharmacology is a medical specialty mentioned in the EU Directive 2005/36/EC.
Optional skills and competences 10 competences
Occupation specific
0 competencesNo competences in this bucket.
Sector-specific
7 competencesevaluate pharmaceutical manufacturing process
Evaluate the ongoing pharmaceutical production process against the latest developments on the market regarding the mixing, compounding and packaging, ensuring the necessary updates are implemented.
improve safety of medicines
Improve the efficacy and safety of medication by promoting evidence-based medicine, development of guidelines and care protocols.
manage adverse reactions to drugs
Analyse and manage adverse reactions to drugs such as general and local anaesthetics and antibiotics, describing the principles of drug challenge and desensitisation to the allergic patient and providing advice on the use of alternative drugs.
perform therapeutic drug monitoring
Select the appropriate laboratory tests for Therapeutic Drug Monitoring and interpret tests to determine whether a drug is producing its desired therapeutic effect in order to use the analysis in minimising drugs adverse effects.
provide specialist pharmaceutical care
Provide specialised personalised support for patients who administer their own medication.
take pharmaceutical inventory
Take stock of medications, chemicals, and supplies, entering the inventory data into a computer, receiving and storing incoming supplies, verifying the supplied quantities against invoices, and informing supervisors of stock needs and possible shortages.
transfer chemicals
Transfer the chemical mixture from the mixing tank to the storage tank by turning on the valves.
Cross-sector
3 competencesperform chemical experiments
Perform chemical experiments with the aim of testing various products and substances in order to draw conclusions in terms of product viability and replicability.
record data from biomedical tests
Use information technology to accurately record and analyse data from biomedical tests, writing reports on the data and sharing results with the appropriate persons.
digital
record test data
Record data which has been identified specifically during preceding tests in order to verify that outputs of the test produce specific results or to review the reaction of the subject under exceptional or unusual input.