Requirements to personnel of the miсrobiological laboratory

Requirements for personnel of the miсrobiological laboratory

Set requirements to personnel  of the microbiological laboratory

Determine the qualifications of personnel, their rights and responsibilities, and also official relationships.

PROCEDURE

Requirements, rights, and duties of employees of the microbiological laboratory are determined in duty regulations.

On arrival at work, the employee must be acquainted with corresponding duty regulations under the signature.

Job Description for Head of the Microbiological  Laboratory

General provisions

General provisions:

The Head of the microbiological Laboratory of Quality Control (hereinafter – the head of the laboratory) is a full-time employee, employed at the enterprise full-time positions.

The main activities of the Head of the laboratory:

Practical implementation of quality policies Enterprises and the resultant issues of quality control, the implementation of programs of the development and improvement of the quality system.

Ensuring the effective functioning of the quality system, as part of an overall quality assurance system in the enterprise.

In its activities, the Head of the laboratory the current legislation and regulations in the sphere of development, production, quality control of drugs; rules of due process (GMP) and good control laboratories (GLP), and the provisions of the European Union in relation to medicines; orders for the enterprise; quality system documents Enterprises; this job description.

The Head of the laboratory is appointed and dismissed by order of the Head of the company.

Job specifications:

As Head of the laboratory is appointed by a person who has higher chemical, biological or pharmaceutical education. As well as those with experience in the industry (quality control of medicines in microbiological laboratories, quality control department). Welcome competence in the theory and practice of GMP, the components of the system to ensure the quality of medicines, confirmed by appropriate certificates.

The Head of the laboratory needs to know:

Normative-legal acts of the Country, regulatory and methodological documents industry governing the creation, production, quality control, and handling of medicinal products.

The basic requirements of the State Pharmacopoeia of the Country and the leading international Pharmacopoeia.

The rules of due process, acting in the Country, GMP regulations of the European Union and other good practices, international standards in the creation, production, and quality control of drugs, the basic requirements for proper documentation systems, staff, self-inspections, and audits, complaints and feedback rules of GLP.

The basis of the labor legislation, regulations, and standards for the protection, safety, industrial hygiene, and fire safety, the basics of the scientific organization of labor.

Work rules, orders, and instructions to the Enterprise, and this job description.

The policy of the company in terms of quality, the basic documentation of the quality system of the Enterprise.

The requirements of applicable laws and regulations for companies protecting trade secrets.

Must own quality control procedures of drugs in accordance with leading international pharmacopeias. Have practical skills to perform quality control methods medicines.

Must be fluent in Ukrainian and Russian, knowledge of English is welcome. Should know computer and office equipment, and Internet access at the user level.

Functions and responsibilities

In accordance with the guidelines of the Head of the laboratory of its functional responsibilities are:

Organizes microbiological analyzes, microbiological control provides that the quality of raw materials and finished products to current standards GMP.

Leading the development of new and improvement of existing methods of microbiological control.

oversees the condition of laboratory equipment and laboratory staff jobs and is taking steps to address the deficiencies.

Monitors the quality of the selection and processing of samples for microbiological control.

To work with the regulatory agency for environmental protection activities.

Develop technical guidance and instructions for routine control of production

Manages the maintenance of installed documentation.

Corresponds with other organizations on issues of microbiological analysis.

conducts and prepares an annual inventory of laboratory equipment.

Develop ongoing and annual work plans of the microbiology laboratory.

Monitors compliance staff safety rules, safety, fire protection, industrial and labor discipline and work rules.

The Head of the Laboratory is responsible for:

Perform the duties assigned to him by this job description.

Compliance with procedures for handling documents, work rules, rights, and legitimate interests of the employees and other citizens.

The proper state of the art security, fire safety and health regulations in the unit.

The proper condition and operation of facilities and equipment used by the laboratory.

Causing damage to the company, the disclosure of trade secrets, and other disorders related to the performance or failure to perform their duties.

For offenses committed in the course of its activities – in the confines of the existing administrative, criminal and civil legislation

Rights

The Head of the Laboratory may:

Submit to the company’s management suggestions for improvement of the laboratory business.

To interact with the leaders of all (some) of the structural departments.

Sign and endorse documents within its competence.

Make proposals on the promotion of distinguished employees, imposing penalties on violators of production and labor discipline.

Require the head of the company to assist in the performance of their duties and rights.

Relationship in

The Head of the Laboratory is subject to QC Head.

Head of the Laboratory for the family in their activities interacts with management, as well as with all parts of the company on issues related to the performance of his duties.

On vacation or a long absence due to illness, travel, etc. Acting Head of the laboratory performed by one of the lab staff, appointed by order of the company according to the report of the Head of the Laboratory.

Job description for Microbiologist

General provisions

Microbiologist of microbiology laboratory of Quality Control (hereinafter – the microbiologist) is a full-time employee of enterprise refers to technical staff.

The main activities of Microbiology are:

Microbiological tests.

Preparation of cultural media.

Keeping the museum strains of microorganisms.

Control of instruments and equipment.

The microbiologist current legislation and regulations of the Country in the sphere of development, production, quality control of drugs; good manufacturing procedure (GMP) and good laboratory practice (GLP), the provisions of the European Union in respect of medicinal products; orders for enterprises, the enterprise quality system documents, this job description.

Appointment as a microbiologist and an exemption by the order of  the Head of company.

Job specifications:

Appointed to the post of microbiologist person who has completed higher education relevant areas of training (magistr, specialist). Work experience in the profession microbiologist – not less than 2 years.

Must know:

Basic requirements of the State Pharmacopoeia of the Country and the leading international Pharmacopoeia.

Fundamentals of total private microbiology.

Fundamentals of labor laws, regulations, and standards for the protection, safety, industrial hygiene and fire safety, and basic scientific management.

  • Work rules, orders and instructions to the Enterprise, and this job description.
  • Company policy in quality, the basic documentation of the quality system of the Enterprise.
  • the requirements of the current legislation and regulatory documents on the protection of trade secrets;
  • Must possess quality control methods of medicines in accordance with and leading international pharmacopoeias. Have practical skills to perform quality control methods medicines.
  • Must be fluent in Ukrainian and Russian, knowledge of English is welcome. Should know computer and office equipment, Internet access at the user level.

The microbiologist should be guided by a Laws of the Country “On the sanitary-epidemiological welfare of the population”, “On protection of labor”, Cabinet of Ministers, the Chief State Sanitary Doctor of the Country, regulations, health regulations, instructions and other regulations relating to sanitary and epidemiological surveillance epidemiological mode, and safe work with pathogens, safety, and quality control of products.

Functions and responsibilities

Conducting microbiological and other tests to ensure that the quality of laboratory testing of raw materials, semi-finished and finished products to current standards, specifications and requirements of environmental safety.

Under the guidance of the Head of Laboratory develops and introduces new methods of laboratory testing, as well as works to improve existing methods.

Takes part in the testing of new and modified product samples, as well as the technical documentation for these products in order to ensure the conditions for the effective control of its quality. Takes part in the preparation of products for state attestation and certification.

Preparing proposals to improve the organization of work for the control of production in order to reduce labor costs for their implementation, as well as improvement of technical standards that set requirements for product quality.

Participates in the development of procedures and instructions for routine control of production, including the rapid analysis in the workplace, is responsible for the correctness and accuracy of their performance.

Supervises the work of the state and control equipment, on time passes it head of the Laboratory for the periodic state inspection.

Exercise control over laboratory equipment and the work places, its compliance with safety standards and is taking steps to address existing deficiencies.

Maintain healthy and safe working conditions in the microbiology laboratory.

Runs primary instruction, quarterly repeated, targeted and unscheduled briefings on health and safety in the workplace with a list of their passage in a special register.

Familiarize:

  • With internal regulations.
  • WIth instructions on labor protection.
  • The organization of the workplace.
  • The safe operation of laboratory equipment.
  • Applies the necessary clothing, footwear and other remedies.

Maintain cleanliness and order in the workplace in general, in the laboratory, utility, residential and other premises of the laboratory.

Meets the requirements of occupational health and hygiene, safety, fire safety.

Pass examinations in the prescribed manner.

Participates in the operational control of the state of safety at stage 1.

Reports on accidents at work or the chief head of the Laboratory of Quality Control.

Clearly leads laboratory notebooks and timely prepares analyzes and tests.

Cooperates with laboratory workers.

Microbiologist is responsible for:

  • For improper performance or non-performance of their duties, which are provided by this job description – within the confines of current legislation on labor.
  • For offenses committed in the course of its activities in the confines of the existing administrative, criminal and civil legislation of the Country.
  • For property damage – within the confines of the existing law and the laws of

Rights:

Familiarize with draft decisions of the company’s management concerning its activities.

Familiarize with the documents that define the rights and responsibilities of the post, the criteria for assessing the quality of the performance of official duties

Submit to the Head of the laboratory or the QC Head  to improve the quality of the work related to the duties prescribed by that statement to make comments on the activities of laboratory workers, offer options to address shortcomings in the activities of the laboratory, within its competence.

Demand and receive  information and documents necessary to perform its duties  in person or on behalf of the Head of the laboratory from  the laboratory staff and employees of other departments .

Ask the Head of the Laboratory to engage, if necessary, experts in other departments to carry out their missions.

Demand that the company’s  managemrs  assist in the performance of their official duties.

Relationship in:

Microbiologists are subject to the Head of the Laboratory and to the Head of quality control.

Microbiologist by the nature of their activities interacts with people from other departments of the enterprises on issues related to the performance of their duties.

During the absence microbiologist (vacation, illness, and other valid reasons) shall act as other microbiologists or Head of the laboratory.

Job description  for Lab assistant 

General provisions

Lab assistant of the laboratory of Quality Control (hereinafter – lab assistant) is a full-time employees, employed at the enterprise full-time positions and applies to engineering staff.

The main activities of a lab assistant are:

  • Preparation to  microbiological analysis.
  • Ensuring the health of the working space.
  • Preparation of job, material and equipment.

In his activities, the lab assistant was guided by current legislation and regulations of the Country in the sphere of development, production, quality control of drugs; good manufacturing procedure (GMP) and good laboratory  practice (GLP), and the provisions of the European Union in relation to medicines; orders for the enterprise; quality system documents Enterprises; this job description.

Appointment to the post of  lab assistant and an exemption is made by the Head of the company.

Job specifications :

The post of lab assistant is assigned to a person with secondary or vocational education, without requiring a  work experience.

Lab assistant  most to know:

  • Guidelines, regulations and reference materials related to the subject of work.
  • Methods of analysis, tests and other studies.
  • Laboratory equipment, test equipment, for his or her operation.
  • How to use computers.
  • The basis of the organization of labor and production.
  • Work rules.
  • The basis of the labor legislation.
  • Rules and standards for the protection, safety, industrial hygiene and fire protection.

Functions and responsibilities:

Preparing culture media, reagents, and solutions.

Performs the installation of glasses and tools for analysis.

Conducts pH determination.

Preparing  inoculum.

Preparing to sterilize glasses and auxiliary material.

Prepares disinfectant solutions, avoiding the use old, lost their activity.

Support job in order disinfecting jobs, boxes, refrigerators, thermostats, and other equipment, decontamination      of waste materials, tools, glasses, uniforms.

After work checks and takes away in certain places containers with cultures of microorganisms, strains,  potent substances; seals incubators, refrigerators, cabinets, gives the press and key person who is responsible for the infectious material or chemicals.

Keep such records in the prescribed forms.

Uses collective and personal protection when working with materials containing BPA.

Strictly performs these rules and instructions from Head of laboratory and microbiologists.

Lab assistant is responsible for:

  • Perform the duties assigned to him or her by this job description.
  • High-quality and timely execution of the work assigned by the menegers in the functional responsibilities.
  • Compliance with procedures for handling documents, work rule.;
  • the proper condition and operation of facilities and equipment used in the physical and chemical laboratory.
  • Preservation and management of material resources of the enterprise.
  • Observance of trade secrets.
  • Violations related to improper fulfillment or non-fulfillment of duties.

Rights:

Acquainted with the projects the company’s management decisions concerning his or her activities.

Inform his or her immediate supervisors about all identified shortcomings during production activity and make suggestions for their elimination.

Relationship in:

Lab assistant subject to  Head of the laboratory.

Lab assistent interact with people from other departments of the enterprises on issues related to the implementation of his or her functional responsibilities.

During absence of  Lab assistant (vacation, illness, etc.), his or her duties shall be appointed the person  in the prescribed manner. This person acquires corresponding rights and responsibility for the proper performance of his or her duties.

REFERENCES :

  1. Job Description for Head of the Microbiological Laboratory.
  2. Job description for Microbiologist.
  3. Job description for Lab assistant.

ABBREVIATIONS:

QC: Quality control.

GMP: Good manufacturing procedure.

GLP: Good laboratory procedure.

BPA: biological pathogen agent