Continuous Improvement Lead
3 days ago
Continuous Improvement Lead (CI) - VDSP, Lalru & VDPP, Baddi Reports To: Strategic Project Manager (SPM) Department: COO - Vaccine Job Location: VDSP, Lalru & VDPP, Baddi Role Summary: To lead and institutionalize continuous improvement (CI) initiatives across the WHO prequalified vaccine manufacturing facility by driving cost reduction, waste elimination, energy optimization,yield improvement and process excellence. The role promotes a culture of innovation, quality initiatives and operational efficiency aligned with cGMP, WHO, and other global regulatory standards. Key Responsibilities: 1. Continuous Improvement & Operational Excellence - Identify and execute improvement projects focused on yield improvement, cycle time reduction, cost savings, and resource optimization. - Promote Lean, Six Sigma, and Kaizen practices across all manufacturing and support functions. - Drive initiatives such as 5S, Visual Management, TPM, to enhance efficiency and reduce variability. - Implement SPC(Statistical Process Control0 and SQC ( Statistical Quality Control) 2. Regulatory Compliance & GMP Alignment - Ensure CI initiatives are aligned with WHO, USFDA, EU-GMP, and cGMP requirements. - Support validation and qualification teams in improving process robustness and data integrity. - Collaborate with QA, QC, and Regulatory Affairs to maintain compliance while improving systems and procedures. - Work closely with manufacturing, QA, QC, RA, Engineering & SCM heads to identify bottle necks and area for improvement. - Partner with functional leaders to standardize processes and reduce variation across plants or departments - Facility CI project governance, tracking, reporting & escalation to COO 3. CI Project Leadership & Execution - Lead cross-functional CI projects across Drug Substance Plant , Drug Product, Formulation, Filling, and Packaging areas. - Develop project charters, timelines, and ROI analysis; track benefits and report to leadership. - Facilitate Kaizen events and root cause investigations (using 5 Whys, Fishbone, FMEA, etc.). 4. Capability Building & Cultural Transformation - Train employees at all levels in Lean principles, Six Sigma tools, and structured problem-solving. - Build CI mind-set across production, quality, engineering, and warehouse teams. - Conduct Gemba walks, performance huddles, and innovation forums to engage teams. 5. Performance Monitoring & Reporting - Establish CI metrics and dashboards (OEE, Waste %, Yield, Downtime, etc.) and monitor regularly. - Track CAPA effectiveness, deviation trends, and quality improvements as part of the CI program. Qualifications & Experience: - Bachelors or Master's degree in Engineering, Pharmacy, Biotechnology, or Life Sciences. - Certified Lean Six Sigma Green Belt or Black Belt (preferred). - Minimum 6-10 years of demonstrated relevant experience in vaccine/biotech/pharma manufacturing, preferably in a WHO-GMP or global regulatory-compliant facility. Key Skills & Competencies: - Strong understanding of GMP, WHO, and global vaccine manufacturing regulations - Proven expertise in Lean, Six Sigma, and Kaizen tools - Analytical, data-driven decision-making - Strong facilitation, coaching, and change management skills - Cross-functional leadership and collaboration abilities - Proficiency in using CI tools/software (e.g., Minitab, Power BI, etc.)
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