Quality Engineer

1. Development of regulatory and registration documentation of the pharmaceutical quality system and making changes to it in the established manner; 2. Maintaining records of regulatory and registration documentation of the pharmaceutical quality system; 3. Checking registration documentation for compliance with established procedures; 4. Organizing the procedure for development, design, issuance, withdrawal, and storage of pharmaceutical quality system documents; 5. Organizing the procedure for review and updating of pharmaceutical quality system documents; 6. Control of changes made to pharmaceutical quality system documents; 7. Maintaining records of documents within the pharmaceutical quality system; 8. Accounting for corrective and preventive actions to minimize or eliminate risks to the quality of medicinal products; 9. Participation in conducting deviations; 10. Approval of qualification and validation protocols for cleanrooms of the cyclotron-radiochemical group, technological processes, cleanroom equipment and the quality control laboratory, and analytical control methods; 11. Checking personnel compliance with the requirements of the regulatory documentation of the pharmaceutical quality system of medicinal products; 12. Checking the functioning of the pharmaceutical quality system processes of medicinal products; 13. Checking compliance with Good Manufacturing Practice requirements by contract organizations (subcontractors); 14. Monitoring the implementation of risk management plans for the quality of medicinal products; 15. Carrying out work on maintaining records of documentation expiration dates, ensuring its timely review, circulation, and withdrawal from circulation of documentation with an expired term; 16. Compilation of Product Quality Reviews, Pharmaceutical Quality System Effectiveness Reviews; 17. Performing work related to the review of the Finished Product Batch Dossier. 18. Participates in conducting: investigations of complaints; investigations of the causes of non-conformities (deviations); self-inspections; audits of suppliers/contractors, compilation of the Approved Supplier List, Approved Contractor List; impact assessment and compilation of change implementation plans; risk analysis.

Requirements

• Basic education: specialist degree, master's degree (technical, chemical-technological, pharmaceutical, or biotechnological).
• English language (technical).

Higher education — specialist degree, master's degree; Experience: 3 years

Conditions

Permissible