Name of qualification Operativni tehnolog/operativna tehnologinja v farmacevtski proizvodnjiAdd to comparison [1]
Translated title (no legal status) Operational technologist in pharmaceutical production
Type of qualification Nacionalna poklicna kvalifikacija, SOK raven 5
Category of qualification Poklicna kvalifikacija
Admission requirements
  • Two years of work experience in the pharmaceutical industry in the field of production preparation, manufacture and packaging of medicines, which the candidate demonstrates on the basis of the employer's certificate of service and a more detailed description of the required tasks for the job for which the certificate is issued.
ISCED field Field
Zdravstvo in socialna varnost
ISCED subfield subfield farmacija
Qualification level

SQF 5
EQF 4

Learning outcomes

The candidate is able to:

  • independently plan, prepare, implement and control their own work and the work of the group in accordance with the quality standards of work in the pharmaceutical industry,
  • prepare technological procedures, procedures for cleaning equipment for product preparation and manufacture,
  • perform process validations,
  • introduce new packaging technologies and prepare the required documentation,
  • introduce new technologies of various pharmaceutical forms,
  • carry out control in the preparation process in accordance with the requirements of technological procedures,
  • carry out controls in the filling / packaging process in accordance with the requirements of technological procedures,
  • perform control in the sterilization process in accordance with the requirements of technological procedures,
  • carry out control in the storage process in accordance with the requirements of technological procedures,
  • in the implementation of the process responsibly and accurately fill in the production documentation, thus ensuring the recording of all parameters during the work that are prescribed, and check for any deviations of the actual parameters from the prescribed and take appropriate action,
  • in its work, constantly observe and ensure work with the guidelines of good manufacturing and good storage practice in pharmaceutical production,
  • maintain personal hygiene and cleanliness of the workplace,
  • check the implementation of preventive maintenance of equipment in accordance with the procedures and implement measures in case of irregularities,
  • to supervise the implementation of reassembly, minor maintenance, 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 for the occurrence of fire or explosion in the performance of work and work so that the amount of waste is as small as possible and the generated waste is sorted in accordance with regulations.

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 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.

VERIFICATION

Practical assessments with oral presentation.

Condition for obtaining certificate

Kandidat dokaže, da dosega znanja, spretnosti in kompetence, določene v katalogu standardov strokovnih znanj in spretnosti.

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.