Name of qualification Name of qualification: Proizvodni procesničar/proizvodna procesničarka v farmacevtski industrijiAdd to comparison
Translated title (no legal status) Translated title: Production process worker in the pharmaceutical industry
Type of qualification Type of qualification: National vocational qualification, SQF level 4
Category of qualification Category of qualification: Vocational Qualification
Admission requirements Entry conditions:
  • at least education at SQF level 2
  • two years of work experience in the production of the pharmaceutical industry, which the candidate proves with the employer's reference letter

 

 

 

 

 

ISCED field Field:
Health and welfare
ISCED subfield subfield: pharmacy
Qualification level

SQF Level: SQF 4
EQF Level: 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,
  • sterilize material and semi-finished products, prepare solutions for injection / infusion, fill sterile pharmaceutical forms and perform optical inspection of filled units,
  • weigh in accordance with regulations, produce solid pharmaceutical forms: granules, mixtures, tablets, capsules, film-coated tablets,
  • prepare and fill semi-solid pharmaceutical forms, suppositories and vaginal globules and prepare liquid non-sterile pharmaceutical forms,
  • prepare PPE for use in sterile and non-sterile production,
  • pack products
  • independently carry out temporary storage of raw materials, packaging and semi-finished products and take care of material flows between warehouses and production,
  • independently carry out cleaning and disinfection of production and auxiliary premises,
  • when carrying out the process, responsibly and accurately fill in the production documentation, thus ensuring the recording of all prescribed parameters during work and checking for possible deviations of the actual parameters from the prescribed ones,
  • in their work, constantly observe and ensure the work with the guidelines of good manufacturing and good storage practice in pharmaceutical production,
  • maintain personal hygiene and cleanliness of the workplace,
  • take care of the used equipment from the point of view of inspection, reassembly, minor maintenance and final cleaning, thus ensuring the smooth operation of production,
  • communicate with superiors and colleagues and take into account the business ethics and values ​​of the company,
  • correctly and safely implement measures that ensure an acceptable level of risk for health problems and the occurrence of fire or explosion during work, and perform work in such a way that the amount of waste is as small as possible and sort the generated waste in accordance with regulations.

Evaluator:

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. Licences may be found here.

Assesment and completion:

VALIDATION

During the guidance process the candidate prepares a portfolio, which is assessed by a committee. If the portfolio submitted by the candidate contains  authentic, valid and adequate proof of the knowledge,  skills and competences defined in the occupational 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  defined in the occupational standard, in which case it will verify  the occupational standard in full.

METHODS OF VERIFICATION OF VOCATIONAL KNOWLEDGE AND SKILLS  

Practical verification with an oral presentation.

Conditions for obtaining a public document:

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 national vocational qualifications are entered in a register of providers maintained in the relevant collection of the National Reference Point for Occupational Qualifications. Providers include: vocational schools, companies, inter-company training centres, adult education centres, chambers of commerce, etc.

URL

Awarding body URL: