Kseniia Denisova

- Participated in the launch and commissioning of new production lines
- Performed quality control and ensured compliance with established quality requirements
- Developed and maintained quality-related documentation
- Conducted assessments and inspections of production equipment
- Trained production personnel on quality control procedures and requirements

- Led the implementation of the Quality Management System (QMS) within the Company
- Developed, implemented and maintained QMS documentation in accordance with applicable quality requirements
- Developed validation and qualification documentation in accordance with established procedures and requirements
- Participated in internal and external audits and supported audit preparation and follow-up

- Organized, coordinated, and supervised validation activities, including Media Fill Tests (MFT)
- Coordinated the localization of new products and the implementation of new raw materials and packaging materials into production processes
- Managed the development, review, and maintenance of documentation for Sterile Manufacturing and Packaging Units, including SOPs, validation protocols and report

- Led and successfully delivered cross-functional projects focused on optimizing production processes and document workflows.
- Implemented process improvements aimed at increasing finished product yield and reducing production losses.
- Optimized batch manufacturing processes to reduce overall production cycle time.
- Reduced batch-to-batch changeover times through process optimization and imp

- Managed cleanroom and controlled environment qualification activities in compliance with GMP requirements.
- Coordinated personnel qualification for work in aseptic areas and ensured compliance with established aseptic practices.
- Managed and performed microbiological environmental monitoring programs for cleanrooms and aseptic areas.
- Performed trend analysis of microbiological monitoring