- Maintain and update Quality Management System (QMS) documentation: Quality Manual, SMF, SOPs, and WI.

- Participate in CAPA, Change Control, and Deviation/Event management processes; maintain relevant registers.

- Lead deviation and event investigations, identify root causes, and implement preventive and corrective actions.

- Implement a new CAPA system, manage CAPA reports, monitor execution, and verify CAPA effectiveness after action closure.

- Manage Change Control process to ensure timely evaluation, approval, and documentation of all changes impacting product quality and compliance.

- Take part in internal and external inspections (including GMP audits) and prepare supporting documentation.

- Contributed to the preparation and documentation of risk management reports related to product quality and GMP compliance.

- Implement a personnel training system for employees; develop training plans and training logs for staff across all departments.

- Organize and conduct personnel training on updated QMS documentation.

- Organized and monitored internal staff training programs using SAP Success Factors VLMS and offline formats, ensuring all personnel received up-to-date knowledge on quality standards and procedures.

- Developed, implemented, and maintained initial and periodic training programs for Quality Control Department personnel, tailored to role-specific responsibilities.

- Planned, organized, and controlled training on new and revised pharmaceutical quality system documents to ensure compliance with GMP requirements.

- Coordinated onboarding and adaptation training for newly hired employees at all stages, supporting their smooth integration into departmental processes.

- Participated in qualification commission meetings for personnel approval to conduct independent work.

- Developed and maintained up-to-date QMS documentation used by QC Department personnel.

- Created, updated, and evaluated the internal list of trainers, ensuring competence and continuous development of training staff.

- Developed and updated the internal “Passport” of the Quality Control Department.

- Entered and verified static data for materials and products in LIMS LabWare for quality control workflows.

- Ensured compliance of electronic documentation with specifications, control methods, and regulatory requirements.

- Updated sampling standards and microbiological control frequencies for raw materials and finished products.

- Maintained accurate data within SAP ERP, including time norms and reagent standards.

- Developed and updated internal laboratory SOPs in compliance with Pharmacopoeia of Ukraine (PhU) and European Pharmacopoeia (Ph. Eur.).

- Prepared analytical reports and verified testing protocols.

- Performed quality control of raw materials, intermediates, and finished products using analytical instrumentation.

- Participated in equipment calibration, qualification, and requalification.

- Maintained laboratory documentation and ensured GMP compliance.