biosafety.kz

Research institute for biological safety problems

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The Research Institute for Biological Safety Problems announces the recruitment of the following specialists:

1 Equipment Engineer

Job responsibilities:

  • performs work on providing equipment and components for capital construction and repair and maintenance needs of the organization;
  • verifies the correctness of determining the requirements for equipment and components in the applications of the organization’s departments and on their basis, as well as in accordance with the title lists and project documentation, compiles consolidated applications with the necessary calculations and justifications;
  • develops schedules for the supply of equipment based on the approved deadlines for the completion of construction and installation work;
  • prepares draft contracts with suppliers, orders for the manufacture of non-standardized equipment, materials for coordination with design organizations of technical conditions for their implementation;
  • monitors the implementation of the organization’s logistics plans, compliance by suppliers with established delivery schedules, quality and completeness of equipment;
  • draws up acts, conducts correspondence on claims in case of violation of contractual obligations by suppliers, coordinates changes in delivery dates, replacement of equipment and components;
  • controls the correctness of the quantitative and qualitative acceptance of equipment and components, their storage, conservation, timely transfer to construction and installation organizations and divisions of the organization;
  • carries out work to identify excess stocks of equipment and components, not installed and unused equipment, makes proposals for its implementation;
  • prepares the data necessary for reporting on the implementation of the organization’s logistics plan.

Must know:

  • legislative and other regulatory legal acts, methodological and normative-technical materials on logistics;
  • prospects for the technical development of the organization;
  • organization of logistical support for the organization;
  • the nomenclature of the necessary equipment and components for the organization;
  • technical characteristics, design features of equipment, components;
  • the procedure for substantiating needs and drawing up applications for equipment and components, concluding contracts with suppliers;
  • fundamentals of production technology;
  • fundamentals of economics, organization of production, labor and management;
  • labor legislation, internal labor regulations, occupational safety and health, industrial sanitation, fire safety requirements.

Requirements:

  • equipment engineer of category I: higher (or postgraduate) education in the relevant field of personnel training and work experience as an equipment engineer of category II for at least 2 years;
  • equipment engineer of the II category: higher (or postgraduate) education in the relevant field of personnel training and work experience as an equipment assembly engineer without a category of at least 3 years;
  • equipment engineer without a category: higher (or postgraduate) education in the relevant field of personnel training without presentation of work experience requirements or technical and professional, after secondary (secondary specialized, secondary professional) education in the relevant specialty (qualification) and work experience as a technician of the first category for at least 3 years.

Conditions:

  • Work in: Zhambyl region, Kordai district, village. Gvardeysky, ul. B. Momyshuly 15.
  • Provision of service housing for non-residents.
  • Registration in accordance with the Labor Code of the Republic of Kazakhstan.
  • Salary based on the results of the interview. The probationary period is  1 – 3 months.
  • Opportunity for self-realization and career growth.

2 Pharmacovigilance

Job Responsibilities

  • Implementation of scientific activities in accordance with the state assignment approved by the Ministry of Health of the Republic of Kazakhstan  , including writing reports, articles and publications related to the implementation of research work and related to the activities of the Institution.
  • Interaction with the World Health Organization, other international and national organizations on the study and prevention of post-vaccination complications, side effects, serious adverse reactions  , unforeseen adverse drug reactions.
  • Analysis and synthesis of materials on the safety of medicines, including administrative decisions of foreign regulatory authorities, publications in scientific journals, study of post-vaccination complications, as well as side effects   , serious adverse reactions of drugs obtained in clinical trials.  Collection, preliminary analysis, timely forwarding, archiving of messages about adverse reactions when using products.
  • Preparation of responses to inquiries on the safety of medicines and immunobiological preparations coming from the Ministry of Health of the Republic of Kazakhstan. Preparation and submission to regulatory authorities of reports on the safety and efficacy of drugs, in accordance with the requirements of legislation and good pharmacovigilance practice:  spontaneous reports of adverse reactions, periodically updated reports on the safety of medicines (PSUR), reports of adverse reactions from clinical trials,  Drug Safety Reports (DSURs).
  • Participation in information and educational activities of the Institution. Conducting trainings for the staff of the Institution on the safety of medicines.
  • Maintenance of the local pharmacovigilance system of the Institution in accordance with the legislation of the Republic of Kazakhstan and international requirements. Writing, updating, and maintaining local pharmacovigilance SOPs and work instructions.
  • Carrying out all necessary activities regarding the preparation of Risk Management Plans and submission to local regulatory authorities.

Requirements

  • Higher medical education;
  • Work experience from 1 year (in the field of pharmacovigilance in pharmaceutical companies, medical institutions, regulatory authorities and / or experience as a doctor in practical health care, preference for clinical pharmacologists);
  • Knowledge of Kazakh and Russian languages. Knowledge of English will be an advantage (level of proficiency –  the skill of reading medical literature, administrative decisions and recommendations with information on the safety of medicines, correspondence);
  • Ability to work with a large amount of information, analytical mindset;
  • Skills in preparing and conducting presentations;
  • Ability to work with search engines and medical databases;
  • Good knowledge of legislation in the field of pharmacovigilance;
  • Responsibility, perseverance, attentiveness, initiative, independence   , focus on results.

Conditions:

  • Work in: Zhambyl region, Kordai district, village. Gvardeysky, ul. B. Momyshuly 15.
  • Provision of service housing for non-residents.
  • Registration in accordance with the Labor Code of the Republic of Kazakhstan.
  • Salary based on the results of the interview. The probationary period is  1 – 3 months.
  • Opportunity for self-realization and career growth.

3 Quality Assurance Specialist

Responsibilities:

  • Validation of technological processes for the production of medicines.
  • Qualification of equipment and clean rooms (IQ, OQ, PQ) and risk analysis of the pharmaceutical quality system.
  • Work with deviations (registration, investigation, corrective measures).
  • Change control (registration, evaluation, implementation, closure of changes).
  • Audit of suppliers.
  • Conducting internal audits (inspection of departments of the organization),  receiving external audits, conducting audits on external orders (outsourcing).
  • Development and maintenance of the organization’s quality management system (development of SOPs, work forms for quality-related processes, in accordance with the requirements of local legislation  , international quality requirements ICH-GCP).
  • Maintaining an archive of paper and electronic documentation.
  • Conducting trainings on the quality management system and related topics (for example, records management,  development of checklists). Preparation and approval of training materials and presentations, monitoring the timeliness of quality assurance trainings and SOPs.
  • Development of a quarterly and annual quality plan.
  • Development, preparation of documents and formation of the registration dossier in the format of ST D in accordance with the requirements of regulatory authorities;
  • Monitoring of rules and requirements for registration in the Republic of Kazakhstan and foreign countries;
  • Liaising with the relevant departments on registration issues.

Requirements:

– Higher specialized education  (standardization and certification, technical, medical, biological, pharmaceutical or chemical-pharmaceutical education) – Knowledge of Kazakh  
 , Russian languages.  Knowledge of English will be an advantage (level of proficiency – study of dossier materials, business correspondence, professional terminology);
– Experience in a pharmaceutical company in the quality assurance department;
– Ability to navigate legislation, regulations and standards;
– Attentiveness, responsibility, learning, non-conflict, sociability;
– Experienced user of Microsoft Office.

Conditions:

  • Work in: Zhambyl region, Kordai district, village. Gvardeysky, ul. B. Momyshuly 15.
  • Provision of service housing for non-residents.
  • Registration in accordance with the Labor Code of the Republic of Kazakhstan.
  • Salary based on the results of the interview. The probationary period is  1 – 3 months.
  • Opportunity for self-realization and career growth.

4 QMD Specialist

Responsibilities:

  • Provides methodological guidance and work on the development, implementation, improvement and certification of the organization’s quality management system.
  • Organizes and participates in internal audits of the organization’s quality management system.
  • Develops regulatory and methodological documents of the quality management system, including a guide to the quality of products.
  • Analyzes the current regulatory documents of the quality management system and makes proposals for their adjustment.
  • Maintains regulatory documents of the quality management system (accounting, storage, amending existing and canceling outdated regulatory documents  , introducing new regulatory documents).
  • Participates in the development, improvement and implementation of the quality management system, organizes work and provides methodological assistance to the structural divisions of the organization on the development of their proposals for improving the quality of products, organizes methodological work with employees authorized for quality in structural divisions.
  • Develops quality programs for immunobiological  preparations, diagnostic test systems, etc., compiles reports on the activities of the organization for quality management of immunobiological preparations, diagnostic test systems,  etc.
  • Presents proposals for improving the quality management system based on the results of internal audits and assessing the effectiveness of the organization’s quality management system.
  • Organizes and participates in the preparation and conduct of certification and inspection audits of the quality management system by accredited bodies.
  • Coordinates design and engineering documentation on the quality management system.
  • Participates as a second party in conducting audits of supplier organizations.

Requirements:

  • higher specialized education (standardization and certification, technical, medical, biological, pharmaceutical or chemical-pharmaceutical education)
  • Kazakh, Russian and English (written and oral) at an advanced level;
  • Direct Knowledge:

– laws and other regulatory legal acts of the Republic of Kazakhstan;

– local regulations, methodological and regulatory documents on the quality management system of the organization; the procedure for the functioning of the quality management system in accordance with the requirements of international and state standards; requirements for conducting internal audits of the quality management system; requirements for the organization;

– registration of the results of certification and inspection audit of the quality management system by accredited bodies; requirements for second-party audits; organization of accounting, procedure and timing of reporting on product quality; fundamentals of economics, organization of production;

– rules for working with a personal computer and other office equipment;

– fundamentals of labor legislation; sanitary and epidemiological requirements for the working conditions of employees of the structural unit of the organization;

– requirements for labor protection, industrial sanitation;

– norms and rules of fire and industrial safety; rules for first aid in case of industrial accidents; internal labor regulations.

Conditions:

  • work in Zhambyl region, Korday district, village. Gvardeysky, ul. B.Momyshuly 15.
  • For non-residents, the provision of service housing
  • salary based on the results of the interview. The probationary period is  1 – 3 months.
  • the possibility of self-realization.

5 Clerical manager

Job Responsibilities

  • Implementation of accounting and registration of documents:

– conducts processing (determining the nature of the issue, sending it for consideration in accordance with the distribution of responsibilities and areas of authority of management, as well as HR classification, control)  and ensures registration of incoming correspondence  ,  registration and dispatch of outgoing documents;

– monitors incoming correspondence from government agencies, processes and classifies requests from government agencies. Interaction with the World Health Organization, other international and national organizations on the study and prevention of post-vaccination complications, side effects, serious adverse reactions  , unforeseen adverse drug reactions.

  • Control over the execution of documents:

– controls the deadlines for the execution of documents and protocol instructions of the Senior Management, analyzes the executive discipline within the framework of the Rules for Documentation and Documentation Management in order to timely execute documents Minutes of meetings, keeps minutes of weekly meetings of the Senior Management in order to record the instructions of the management and ensure their execution;

– implementation of work on the GR function;

– monitors incoming correspondence from government agencies, international collaborators, processes and classifies requests from government agencies.

  • Organization and implementation of official meetings of the organization.

Requirements

  • higher legal / economic / pedagogical / psychological or in the field of personnel management);
  • at least 1 year in HR records management or in the relevant field of activity;
  • Knowledge of Kazakh, Russian and English languages at the level of fluency Knowledge of English (availability of an  Ielts  certificate – 7);
  • the ability to positively influence people, organize meetings;
  • Ability to work with a large amount of information, analytical mindset;
  • Skills in preparing and conducting presentations;
  • Ability to work with search engines and databases;
  • Good knowledge of legislation, knowledge of regulatory legal acts of the Republic of Kazakhstan in the field of employment, document management and record keeping; (Labor Code of the Republic of Kazakhstan);
  • possess modern management methods;
  • have experience in administrative work, administrative talent, have experience in the field of economic activity;
  • be enterprising in expanding the scope of activities;
  • have a high level of professional communication culture;
  • be able to provide corporate support, business competence;
  • personal qualities, genetic predisposition to leadership,  the presence of a developed management concept;
  • have a sense of inner freedom and willingness to take risks;
  • critically evaluate their achievements;
  • be able to harmonize interpersonal relationships;
  • Responsibility, perseverance, attentiveness, initiative, independence   , focus on results;
  • Have a letter of recommendation from a previous employer (at least 1 or 2).

Conditions:

  • Work in: Zhambyl region, Kordai district, village. Gvardeysky, ul. B. Momyshuly 15.
  • Provision of service housing for non-residents.
  • Registration in accordance with the Labor Code of the Republic of Kazakhstan.
  • Salary based on the results of the interview. The probationary period is  1 – 3 months.
  • Opportunity for self-realization and career growth.

Head of the Administrative and Personnel Department: Azamat Atarkululy Ashirbekov
Phone: +7-726-36-7-22-28 (ext. 115)
Email address: ribsp@biosafety.kz , a.ashirbekov@biosafety.kz