Industrial Pharmacist with extensive experience in organisation, international project management, Quality Management and GxP compliance.Broad experience in developing, shaping, and leading a comprehensive and cohesive quality system that maximizes compliance, business continuity and efficiency and is in compliance with European and American requirements.Pharmaceutical and Medical Device IndustrySpecialties: - Process and organisation optimisation,- Risk Analysis Based Approaches,- International and multi-site project management including Change Management,- Audits and inspections,- Continuous Improvement- Quality System: Deviations, OOS, OOT, CCR, CAPA, SOP - Product Release and Batch Record Management- Regulatory, Quality and Pharmacovigilance Agreements,- Validation of computerised systems,