Speakers

IPQA Officer | LM Manufacturing Ltd (Zydus Pharmaceuticals UK) Weedon Bec, England | July 2022 – Present • QMS Management: Support and maintain core elements of the Quality Management System, including documentation control, change control, and product quality reviews. • Compliance Oversight: Ensure all production activities strictly adhere to current GMP, GDP, and regulatory requirements, as well as internal SOPs and Health & Safety policies. • Issue Resolution: Lead investigations into deviations and product quality escalations, performing Root Cause Analysis (RCA) and implementing effective CAPAs. • Operational Excellence: Review and propose strategic improvements to production workflows to enhance efficiency while maintaining high-quality standards. • Documentation: Author and update technical instructions and Standard Operating Procedures (SOPs) to reflect current best practices. • Training: Conduct GMP training sessions for staff to ensure continuous compliance and high safety standards across production areas. Production Coordinator | LLC "BIOLAB DIAGNOSTIC" Kyiv, Ukraine | Sept 2020 – March 2022 • Quality Leadership: Directly supported the Head of Quality and Qualified Person (QP) in the implementation and oversight of all organizational quality activities. • Strategic Planning: Managed operational performance and delivered on Key Performance Indicators (KPIs) to align with business strategy and regulatory compliance. • Workflow Coordination: Synchronized activities between various departments to facilitate smooth production schedules and timely delivery to customers. • Staff Development: Identified training needs, proposed external training programs, and mentored team members on diverse GMP topics. Head of Marketing / Business Unit Head | LLC "BIOPHARM" Kyiv, Ukraine | Sept 2018 – Sept 2020 • Executive Management: Led and motivated cross-functional teams (including 5 Key Account Managers) to achieve significant market penetration. • Growth Performance: Delivered exceptional commercial results, including a 281% increase in revenue and over 10,000% growth for specific product lines (Bioclot A). • Stakeholder Engagement: Collaborated with healthcare authorities and NGOs to improve patient access to innovative treatments and established new projects for rare diseases.