Job description for a bacteriologist

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Job description for a bacteriologist. Full document

Occupational Safety and Health

Occupational Safety and Health / Job descriptions

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I. General Provisions

This Job Description defines the duties, rights and responsibilities of a bacteriologist associated with the production of medicines, vitamins, medical, bacterial and biological preparations and materials.
The bacteriologist reports directly to _______.
The bacteriologist follows the instructions of _______.
The bacteriologist replaces _______.
The bacteriologist is replaced by _______.
Must know:

production technology;
technological and laboratory equipment, instruments and operating rules;
standards, specifications, as well as regulations, instructions and other guidance materials for the production and control of products;
experience of advanced domestic and foreign enterprises in the field of production of similar products;
fundamentals of labor legislation;
rules for maintaining technological documentation;
rules and norms of labor protection, industrial sanitation and fire protection.

Qualification requirements:

Leading bacteriologist (production of medicines, vitamins, medical, bacterial and biological preparations and materials): complete higher education in the relevant area of training (master, specialist) and advanced training. At least 2 years of work experience in the profession of a bacteriologist of category I.
Category I bacteriologist (production of medicines, vitamins, medical, bacterial and biological preparations and materials): complete or basic higher education in the relevant field of study (master, specialist or bachelor) and advanced training; for a master - without requirements for work experience, for a specialist - at least 2 years of work experience in the profession of a bacteriologist of the II category, for a bachelor - at least 3 years.
Category II bacteriologist (production of medicines, vitamins, medical, bacterial and biological preparations and materials): complete or basic higher education in the relevant field of study (specialist or bachelor) and advanced training; for a specialist - no requirements for work experience, for a bachelor - at least 2 years of work experience in the profession of bacteriologist. Bacteriologist (production of medicines, vitamins, medical, bacterial and biological preparations and materials): complete or basic higher education in the relevant field of study (specialist or bachelor) without requirements for work experience.

II. Official duties

Bacteriologist:

Carries out work on checking the microbial contamination of medicines.
Carries out work to improve production technology, methods of laboratory analysis, testing and research work on the development, development and introduction into production of new drugs, progressive technological processes.
Provides timely and high-quality bacteriological control of finished products.
Controls microbial contamination of raw materials, excipients, packaging materials.
Controls the personal hygiene of personnel, production sites and workshops.
Controls the sanitary condition of the air, equipment and communal industrial premises.
Organizes and carries out the correct and timely production, control and storage of nutrient media, preparation of the box for sowing under sterile conditions, checking the sterility of the box and overalls.
Controls the mode of sterilization of dressings, sterile tampons, the correctness of records and maintenance of workshop technological journals ensures the storage of archival samples with their delivery to the workshop.
Gives recommendations on how to improve sterilization modes, their improvement.
He masters new methods of product sterility control and teaches laboratory workers.
Draws up applications for raw materials, materials, inventory, equipment, nutrient media, which are necessary for the normal operation of the laboratory.
Monitoring the condition of devices, equipment, correct operation.
Carries out control over the timely technical inspection of the GPSD-1000 cabinets, prepares it for inspection.
Organizes and carries out the necessary accounting and reporting of the bacteriological laboratory, maintains technical documentation of the technical control department (QCD).
Reports in a timely manner to the head of the Quality Control Department on comments, violations, deviations in the sterilization regime in the workshops, the appearance of bacterial growth in finished products; warns the shop about the possibility of product defects.
Communicates with research institutes on special issues of methods and analyses.
Keeps the bacteriological laboratory clean and tidy, organizes work in accordance with established labor protection standards.
Participates in the development of regulatory and technical documentation, reviewing technological regulations in order to ensure the release of medicines that meet the standards of microbial purity.
Prepares quarterly reports on microbial contamination of products, raw materials, equipment.

III. Rights

The bacteriologist has the right:

Get acquainted with the draft decisions of the management of the enterprise regarding its activities.
Participate in the discussion of issues related to the performance of his duties.
Make suggestions for improving the work related to the provisions of this instruction.
Within the limits of his competence, inform his immediate supervisor about all those identified in the course of his activities, and make proposals for their elimination.
Require the management of the enterprise to assist in the performance of their duties.

IV. A responsibility

The bacteriologist is responsible for:

For improper performance or non-performance of their official duties, as well as for non-use or directly to their rights provided for by this Job Description - to the extent determined by the current legislation of Ukraine.
For offenses committed in the course of carrying out their activities - within the limits determined by the current administrative, criminal and civil legislation of Ukraine.
For causing material damage - within the limits determined by the current labor legislation on labor of Ukraine.

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