SUNIL KUMAR
Gujarat
Summary
Strategic and performance-driven Pharmaceutical Quality & Operational Excellence Leader with 20+ years of experience in QC/QA leadership within globally regulated manufacturing environments. Proven expertise in deploying Process Excellence frameworks, Lean Management Systems, laboratory digitization, business process redesign, and regulatory compliance transformation. Demonstrated success in leading cross-functional teams, driving productivity through benchmarking, simplifying workflows, eliminating inefficiencies, and fostering a culture of continuous improvement aligned with global quality standards. Experienced in handling international regulatory audits including WHO, TGA, ANVISA, SAHPRA, and ROW markets. Strategic Pharmaceutical Quality & Operational Excellence Leader with 20+ years in QC/QA leadership. Led end-to-end Quality Control operations for OSD products, achieving >95% turnaround time through implemented KPIs and structured benchmarking. Drove digitisation initiatives and process simplification, enhancing laboratory productivity by 20% and fostering a culture of continuous improvement.
Overview
19
19
years of professional experience
1
1
Certification
Work History
QC Head
Aristo Pharmaceuticals Ltd.
Daman
09.2023 - Current
- Lead end-to-end Quality Control operations for OSD (Tablets, Capsules, Liquids, Suspensions) catering to India and ROW markets.
- Operational Excellence & Process Transformation
- Deployed Laboratory Excellence Achievement Program (LEAP) integrating Lean principles to eliminate non-value-added activities and improve laboratory productivity.
- Implemented structured benchmarking and KPIs to enhance turnaround time (TAT) achievement to >95%.
- Led digitization initiatives including EDMS, LMS, TrackWise, LIMS optimization and CSV compliance.
- Drove process simplification through Kaizen, 5S and Quality Circles reducing NVA by 20%.
- Streamlined analytical workflows improving productivity by 20%.
- Business Process Redesign
- Conducted stakeholder workshops across QC, QA, Production and Supply Chain to redesign QC release processes.
- Standardized SOP governance and audit trail review process in EDMS.
- Redesigned stability and validation reporting processes within LIMS for scalability and compliance.
- Integrated quality metrics into site-level dashboard for data-driven decision making.
- Innovation & Simplification
- Facilitated structured ideation programs for laboratory automation and digital workflow improvement.
- Implemented automation in documentation and review processes.
- Reduced manual dependency and strengthened data integrity compliance.
- Team Development & Leadership
- Lead a team of 55+ professionals including microbiology laboratory.
- Built leadership bench strength through structured learning via LMS.
- Conduct performance dialogues linked to sustainability, zero defect and zero waste goals.
- Foster collaborative culture across cross-functional teams (CFT).
Site Compliance Head & QC Head
Sun Pharma Ltd.
Jammu
05.2014 - 08.2023
- Led Quality Control and Site Compliance for regulatory-approved OSD manufacturing unit.
- Operational Excellence Highlights
- Led site compliance management for multiple global audits.
- Implemented Lean Six Sigma initiatives for process control and deviation reduction.
- Strengthened investigation governance framework (OOS, OOT, Deviation, CAPA).
- Improved audit readiness maturity and inspection outcomes.
- Process & Compliance Governance
- Developed quality metrics dashboard for performance monitoring.
- Led cross-functional CAPA effectiveness reviews.
- Standardized risk-based investigation and change control mechanisms.
Section Head – QC Operations
Cipla Ltd.
Baddi
06.2007 - 04.2014
- Managed QC operations for OSD, DPI, MDI & Lozenges in WHO/TGA-approved facility.
- Improved analytical capacity utilization.
- Enhanced process control robustness.
- Strengthened global regulatory inspection preparedness.
Education
Executive Program in LOM & Six Sigma - Lean Operation Management
IIM Rohtak
Rohtak, HR2023
M.Sc. - Chemistry
VMU
Salem, TN2012
B.Sc.B.Ed. - PCM
HPU
Shimla, HP2001
PGDM (Tech) - Technology
IIM Sirmaur
Sirmaur,HP01.2026
Lean Six Sigma Black Belt - Lean Six Sigma Methodlogy
Benchmark Six Sigma
01.2025
Skills
- Operational Excellence
- Lean Transformation
- Quality assurance
- Process optimization
- Regulatory compliance
- Data analysis
- Risk management
- Lean Six Sigma
- Team leadership
- Quality metrics
- Laboratory management
- Communication excellence
- Quality Management
- KPI tracking
- Strategic planning
- Automation technology familiarity
- Operational efficiency
- Staff recruitment
- Process Excellence Framework Deployment
- Lean Six Sigma Black Belt
- Business Process Redesign
- Continuous Improvement
- Kaizen
- Laboratory Digitization
- Regulatory Compliance
- QMS
- Investigation
- RCA
- CAPA Governance
- Audit Readiness
- Global Inspections
- Change Management
- Stakeholder Alignment
- Team Development
- Capability Building
- Data Analytics
- Quality Metrics
- LIMS
- EDMS
- LMS
- TrackWise
- SAP
- Minitab
- Empower
- Chromeleon
- GAMP 5
- CSV
- Data Integrity Compliance
Accomplishments
- 100% productivity with 99.95% analytical accuracy.
- Reduced non-value-added laboratory activities by 20%.
- Improved testing turnaround time compliance to 95%+.
- Successfully led automation and digital transformation projects.
- Certified Lean Six Sigma Black Belt.
- Led multiple successful global regulatory audits.
Custom Section
- Operational Excellence & Lean Transformation
- Process Excellence Framework Deployment
- Lean Six Sigma Black Belt (LSSBB)
- Business Process Redesign (BPR)
- Continuous Improvement & Kaizen
- Laboratory Digitization (LIMS, EDMS, LMS, TrackWise)
- Regulatory Compliance (WHO, TGA, ANVISA, CDSCO)
- QMS, Investigation, RCA & CAPA Governance
- Audit Readiness & Global Inspections
- Change Management & Stakeholder Alignment
- Team Development & Capability Building
- Data Analytics & Quality Metrics
Languages
Hindi
Advanced
C1
Certification
Certifications:
· 2006: Certified Computer Course from CEDTI
· 2023: Certified Executive program on LOM & Six Sigma from IIM-Rothak.
· 2025: Certified LSSBB from Benchmark Six Sigma.
Timeline
QC Head
Aristo Pharmaceuticals Ltd.
09.2023 - Current
Site Compliance Head & QC Head
Sun Pharma Ltd.
05.2014 - 08.2023
Section Head – QC Operations
Cipla Ltd.
06.2007 - 04.2014
Executive Program in LOM & Six Sigma - Lean Operation Management
IIM Rohtak
M.Sc. - Chemistry
VMU
B.Sc.B.Ed. - PCM
HPU
PGDM (Tech) - Technology
IIM Sirmaur
Lean Six Sigma Black Belt - Lean Six Sigma Methodlogy
Benchmark Six Sigma