Polina Chepik

Process Engineer USP&DSP (Sep 2023 – Present): GMP documentation (SOPs, BMR/MBR), deviations, CAPA, change control, risk assessments, process documentation, cross-functional collaboration. Process Engineer F&F (Jun 2021 – Aug 2023): cleanroom design for vial/PFS (aseptic GMP), equipment and material selection, URS, validation (IQ/OQ/PQ), FAT, GMP training.

Promoted from Junior to Senior Engineer within 2.5 years. GMP documentation lifecycle (MBR, SOPs, Master Formulas), risk analysis for process changes and deviations, technology transfer support (site-to-site). Key user SAP (PP/QM), improving data accuracy. CTD Module 3 documentation and GMP training for production staff.

Coordination of GMP documentation for sterile and solid dosage forms across CMOs

GMP documentation preparation and compliance monitoring in pharmaceutical manufacturing Material calculations and equipment qualification support (IQ/OQ) Pilot batch production participation during technology transfer activities

Supervision of solid dosage (tablet) manufacturing processes in compliance with GMP standards Production preparation and material flow coordination to ensure efficient operations Monitoring of process compliance with SOPs and quality requirements

Medication dispensing and patient counseling in compliance with pharmaceutical regulations