Name of qualification Procesničar/procesničarka v proizvodnji farmacevtskih učinkovinAdd to comparison [1]
Translated title (no legal status) Process worker in the production of pharmaceutical ingredients
Type of qualification Nacionalna poklicna kvalifikacija, SOK raven 4
Category of qualification Poklicna kvalifikacija
Admission requirements
  • at least education at SQF level 2
  • two years of work experience in the pharmaceutical or chemical industry, as evidenced by the candidate's employer's letter of reference
ISCED field Field
Zdravstvo in socialna varnost
ISCED subfield subfield farmacija
Qualification level

SQF 4
EQF 4

Learning outcomes

The candidate is able to:

  • independently plan, prepare, implement and control their own work in accordance with the quality standards of work in the pharmaceutical industry of active ingredients,
  • perform the biosynthetic fermentation process of an individual product from the beginning of the process of batching of raw materials and perform all subsequent stages until the final packaging of the product,
  • carry out the synthetic process of production of the active pharmaceutical ingredient from the beginning of the process of batching of raw materials and carry out all subsequent stages of reaction, extraction, crystallization, drying to the final packaging of the product,
  • independently and qualitatively carry out the final stage of packaging of an individual product, where it is crucial that the product is properly packaged and labeled, thus ensuring further stability and traceability on this product,
  • during the process of carrying out the work, to ensure the proper storage of input raw materials that are incorporated into the process, as well as the proper storage of the final product,
  • when carrying out the process, responsibly and accurately fill in the production documentation, thus ensuring the recording of all parameters during the work that are prescribed, and to check for possible deviations of the actual parameters from the prescribed ones,
  • in its work, constantly observe and ensure work with guidelines of good production and good storage practice in the production of active pharmaceutical ingredients,
  • maintain personal hygiene and cleanliness of the workplace,
  • take care of the equipment it uses, from the point of view of control, minor maintenance and final cleaning of the equipment, thus ensuring the smooth operation of production,
  • communicate with superiors and colleagues and take into account the business ethics and values ​​of the company,
  • safely perform work in the EX environment (where explosion zones are prescribed due to the possible presence of solvent vapors), in chemical syntheses with knowledge of all laws applicable to work in such an environment, and comply with regulations to protect health and the environment, equipment or entire production with a focus on the highest quality and safest work performed.

Accessors

Verification and assessment are carried out by committees for the verification and validation of national vocational qualifications, appointed by the National Examination Centre (NEC). Committee members must be licensed by the National Examination Centre.

Assessment and completion

VALIDATION

During the guidance process the candidate prepares a portfolio, which is evaluated by a committee. If the candidate has submitted authentic, valid and relevant proof of knowledge, skills and competences from the operational standard, the committee may:

  • validate the contents of the occupational standard in full,
  • validate the contents of the occupational standard in part and define the knowledge, skills and competence to be verified,
  • refuse to validate any of the contents of the occupational standard because the candidate has not provided proof of any of the knowledge, skills and competences under the occupational standard, in which case it will verify the occupational standard in full.

ASSESSMENT METHOD

Practical assessment with oral defense

Condition for obtaining certificate

Candidates demonstrate attainment of the knowledge, skills and competences defined in the catalogue of standards of vocational knowledge and skills.

Awarding body

Providers of procedures for identifying and validating NVQs are entered in a register of providers maintained in the collection of the national information centre for vocational qualifications. These are: vocational schools, businesses, B2B training centres, adult education centres and chambers of commerce.