A dynamic, proactive senior management expert with extensive experience in pharmaceutical quality control and assurance, manufacturing, validation, and compliance and regulatory knowledge.

• Expertise in leading projects involving documentation, systems setup, reviewing processes, technical transfer of products into facilities
• Auditing both internal and external having audited around the world
• Batch disposition, Change Control, Non-Conformance and Deviations, Complaints, Vendor Management CAPA systems
• Remediation activities
• Equipment, processes (secondary and API), utilities including an Subject Matter Expert (SME) for Purified Water and Water for Injection systems
• Cleaning, equipment and process validation, calibration, workflow analysis, and efficiency enhancement whilst adhering to stringent food and drug administration’s (FDA) and European Regulations in relation to GMP, GDocP, GDP and GCP
• Providing leadership and overall strategic and managerial direction for design and execution of validation studies throughout sites
• Developing employee skills through assignment and delegation of tasks, performance evaluation, and providing apposite feedback and training. Empowering and motivating colleagues to lead with creative thinking and positive attitude