Обязанности и достижения:
Deploy and maintain Regional Quality Management System (QMS), including document management, training, change control, deviation, CAPA management, quality issues handling.
• Implement Supplier Quality Program, including selection & qualification and ongoing quality performance monitoring of the suppliers, which provide materials and services with GxP/product quality impact, and Quality Assurance agreements.
• Establish and lead internal audit/self-assessment program across the region, to evaluate compliance with product quality systems & processes, and to identify improvement opportunities.
• Develop and execute Annual Quality Plan in the region, including establishment and maintenance of the local risk register. Engage the key stakeholders to proactively identify quality risk areas, and establish appropriate risk mitigations and risk monitoring program.
Recruited, trained and developed effective multinational regional Quality team.
• Developed and implemented regional Quality Strategies with a focus on compliance to the quality requirements ensuring and Quality Culture driving and strengthening at the LOCs.
• Built efficient Regional QMS from ground up within 24 months:
1. initiated and led development of Policies and Standards describing the quality relevant processes (over 200),
2. identified training needs for the entire CIS Business Community, developed training program and partnered with LOCs’ Senior Management on trainings execution,
3. implemented harmonized audit readiness and management program at the LOCs, 4. drove improvement and remediated gaps in Supplier Quality Management by negotiating over 100 Quality Agreements following comprehensive audits.
• Converted Business Development ideas into reliable Product Quality Assurance solutions.