1. Quality and Laboratory Set-Up (Greenfield):
• Lead the design and establishment of laboratory infrastructure, equipment selection, and standard operating procedures (SOPs).
• Develop and implement QMS from the ground up to ensure full compliance with regulatory and industry standards.
• Establish robust Quality Assurance (QA) and Quality Control (QC) processes, documentation systems, and reporting mechanisms.
• Define key quality metrics and ensure accurate data collection and analysis.
2. Quality Management & Continuous Improvement:
• Oversee daily QA/QC operations to maintain high product standards.
• Implement Lean Six Sigma (Green Belt) principles to optimize processes, reduce variability, and improve efficiency.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
• Ensure compliance with ISO standards, regulatory requirements, and customer specifications.
3. Leadership & Team Development:
• Recruit, train, and develop a high-performing quality and laboratory team.
• Foster a culture of continuous improvement and accountability.
• Provide mentoring and support to team members to enhance skills and performance.
4. Collaboration & Stakeholder Management:
• Work closely with cross-functional teams including production, R&D, and supply chain to maintain product quality.
• Engage with suppliers and external auditors to ensure quality consistency across the supply chain.
• Communicate quality performance and improvement plans to senior management.