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Qualification: Industrial Pharmacist (RTU)

Industrial Pharmacist (RTU)

Qualification Information

 Graduates of the study program are able:
- to integrate in a cross-disciplinary team, share team’s aims and make contribution to reaching the common aims;
- to integrate theoretical knowledge gained studying pharmacy and industrial pharmacy, and if necessary to develop knowledge independently to solve problems and substantiate their opinion;
- to find, select, analyze, and use relevant research literature, to process and critically analyze the data, to provide assessment and present results;
- to evaluate the validity of the data and make decisions on further actions;
- to select the most appropriate and innovative solutions to the problems.



Competences:

1. Basic knowledge of:
1.1. socio-psychological, administrative and economic management methods;
1.2. business and economic principles and intellectual property rights, basic principles of patent interpretation;
1.3. pharmaceutical and technology development areas;
1.4. basic principles of design, construction and maintenance of industrial buildings and work environment-related utilities.
2. Understanding of:
2.1. types of active pharmaceutical ingredients and production technology;
2.2. basic principles of the development of large-scale synthesis methods;
2.3. application of biotechnology, nanotechnology in medicine production, genome medicine production, quality assurance, registration and use thereof;
2.4. types of packaging, selection principles;
2.5. drug manufacturing equipment, operating principles and use thereof, work environment and safety aspects;
2.6. basic principles of scaling;
2.7. medicine distribution preconditions, including safety, efficiency, quality and pharmaco-economic evaluation of medicine;
2.8. organization and monitoring of distribution of medicines and other healthcare products, basic principles of pharmaceutical marketing;
2.9. a qualified person's role and responsibilities.
2.10. the role and functions of marketing and sales departments;
3. Ability to apply knowledge of:
3.1. physicochemical, toxicological properties of active substances and correlation thereof with biological activity;
3.2. origin and type of purification, characterization and analysis of active pharmaceutical ingredients and excipients;
3.3. pharmacokinetic process;
3.4. pharmaco-dynamic process;
3.5. finished dosage forms, production processes thereof;
3.6. basic principles of dosage form composition, excipients and range of options, depending on the production technology;
3.7. active pharmaceutical substances, excipients, packaging compatibility;
3.8. guidelines of the Good Manufacturing Practice (GMP);
3.9. quality systems applicable to the pharmaceutical sector;
3.10. medicine stability studies, analytical methods and validation process;
3.11. quality requirements f the production processes in both small and industrial-scale manufacture of pharmaceutical products, including standard operating prescriptions (SOPs) and supervisory standards in order to achieve the appropriate level of quality;
3.12. the relative importance of quality control testing and production monitoring to assure product quality.
3.13. various analytical methods and their appropriate application in the analysis of pharmaceutical products;
3.14. properties of borderline products and cosmetics;
3.15. the role of drug registration and registration procedures;
3.16. clinical trials from the first human tests to post-registration trials of phase 4, objectives, organization and management thereof;
3.17. personal development, management and communication psychology;
3.18. regulations governing professional activities;
3.19. principles of professional and general ethics;
3.20. basic principles of statistical data analysis;
3.21. information technologies;
3.22. document management basics;
3.23. environmental protection;
3.24. official language;
3.25. two foreign languages at a communication level;
3.26. professional terminology in the official language and at least two foreign languages;
3.27. labour protection;
3.28. employment relationship.



Skills:

1. To develop the composition of finished dosage forms with respect to physicochemical properties of active substances and excipients, pharmacological and toxicological properties of active substances.
2. To select the most appropriate adjuvants, technologies, packaging materials in the development of finished dosage forms, based on research results.
3. To be able to assess the impact of production and storage conditions on the quality of medicinal products.
4. To develop and validate analytical methods for the quality assessment of active substances, excipients, materials, intermediates and finished products (finished dosage forms) according to the European Pharmacopoeia.
5. To understand the nature of different methods of analysis and apply them in pharmaceutical products analysis.
6. To standardize finished dosage forms and prepare documentation in compliance with the Good Manufacturing Practice (GMP) of medicine and ES guidelines, depending on market requirements.
7. To develop a quality control system in pharmaceutical companies.
8. To manage a quality control system in pharmaceutical companies.
9. To perform quality control (testing) and batch release and certification.
10. To assess the risks of medicine manufacturing and act in accordance with the procedures within one's competence.
11. To understand the relative importance of quality control testing and production monitoring to assure product quality.
12. To ensure medicinal manufacturing processes in accordance with the requirements of documents governing pharmaceutical activities.
13. To ensure the compliance of the products in accordance with the requirements of technology and quality documentation.
14. To monitor the development of regulatory and binding documentation of medicine production.
15. To ensure accurate completion of binding documentation and compliance thereof with the technological process.
16. To ensure the movement of psychotropic drugs (production, storage, dispensing and inventory) in accordance with laws and regulations.
17. To be precise and observe labour protection regulatory requirements, dealing with medicinal products and active substances, schedule II, III drugs, precursors.
18. To develop, analyse and update the production consumption norms of raw materials and consumables.
19. To plan and rationally use medicinal plant capacity, material and personnel resources.
20. To develop and provide drug manufacturing and finished product delivery plans, carry out labour intensity calculations, production equipment load calculations.
21. To understand the basic principles of drug manufacturing facilities, work environment-related utilities and manufacturing equipment design, understand the importance and impact of selection, purchase, maintenance, servicing and repair thereof on the quality of the manufacturing process.
22. To understand the role of audits within a pharmaceutical company.
23. To observe amendments and act in accordance with the laws and regulations of the Republic of Latvia, EU and the Council in the field of manufacture, circulation and registration of medicine.
24. To determine the affiliation of borderline products, consider the difference between cosmetics, dietary supplements and medicines.
25. To provide storage and distribution of medicinal products in accordance with the Good Distribution Practices (GDP) and EU guidelines.
26. To understand the organization and supervision of distribution of medicines and other healthcare products, including provisions relating to the marketing (trade) of medicinal products.
27. To understand a qualified person's role and responsibilities.
28. To understand benefits and risk assessment in relation to animal and clinical studies.
29. To ensure manufacturing and logistics of investigational medicinal products.
30. To participate in the development of clinical trial programs/protocols and presentation thereof in accordance with the requirements of the Good Clinical Practice.
31. To monitor the progress, timely conduct of clinical studies, collection of results and preparation of report in accordance with the requirements of the Good Clinical Practice.
32. To advise colleagues, healthcare professionals, students in the field of medicine production and quality assessment.
33. To continuously improve knowledge and skills and contribute to the development of the field of medicine manufacture and pharmacy in Latvia.
34. To observe the basic principles of professional and general ethics.
35. To use and comply with laws and regulations governing the pharmaceutical, chemical, medical and health care organizations and personal data protection.
36. To plan scientific research, prepare projects, participate in the implementation thereof.
37. To obtain information, using literary data and databases.
38. To determine the degree of evidence of pharmaceutical research data.
39. To work in accordance with the level of scientific and technological development on the basis of evidence-based principles.
40. To write scientific articles and reports in the field of pharmacy.
41. To build and maintain effective communication.
42. To be part of a multi-disciplinary team within one's competence.
43. To know the official language.
44. To use professional terminology in the official language and at l

Reference Data

EQF Level:
Thematic area:
Information Language:
Location:
NQF Level: 
7
Awarding body: 

- Riga Technical University

Awarding body contact info: 

KAĻĶU IELA 1, RĪGA, LV-1050
Tālr.: 67089300
Fakss: 67820094
E-pasts: rtu@rtu.lv

Source of information: 
National occupation classification: 

ISCO-08

Relationship type: 

Industrial pharmacist (2262 03)

Access requirements: 

Higher education qualification of LQF level 6 (bachelor, professional bachelor or professional higher education qualification) in the same or compatible branch of science or professional field of higher education, as well as a certain professional experience laid down by higher education institution

Ways to acquire: 

Formal (through education programmes)