DIPAK SELOT

Visionary and accomplished Senior Director with a proven track record of over 24+ years in Quality Assurance, Quality Control, Quality Compliance, Manufacturing, Projects, and Contract Manufacturing Organisations Management (CMOs across the globe).

Expert in developing and implementing strategic Quality Systems that thrive in compliance with global regulatory standards, including FDA, EMA, and ISO, while enhancing operational efficiency and Product Quality.

Skilled in Steering cross-functional Global teams to execute large-scale initiatives, optimize processes, and foster a culture of excellence and innovation.

Highly experienced in overseeing audits and risk management, ensuring readiness for regulatory reviews and proactive mitigation of compliance risks.

Adopt building and maintaining strategic partnerships with CMOs, vendors, and stakeholders to align objectives, and deliver on organizational goals.

• Key role in 21st Century Quality Initiatives across Sun (technical exert for Investigations)
• Technical SME for Product Quality –Centre of Excellence
• Certified Master Trainer for product robustness by Light Pharma Inc.
• Certified Master Coach for Lean operation by McKenzie
• Certified by -Franklin Covey –Leadership Workshop
• The idea engine implemented more than 500 ideas with the help of the team
• Nominated as Core team member for Aspire project –Reduction of Muda
• Certified GEMBA walk-excellence workshop
• Certified Lead Investigator by QxP / Lachman and Light Pharma LLC
• Active participation in resolving Product robustness issues across all sites
• Core Team member for Regulatory meeting –US FDA Attended 2 Regulatory F2F meeting with FDA
• Technical reviewer and writer for Global SOPs / Best practices and Quality Newsletters
• Managed 5 pharma projects to complete in time with an investment of Rs. 600 Crores and commissioned
• Successfully executed project within 9 months and the plant got approval by TGA within 4 months of a successful production
• Record holder increase in production capacity across all sites
• Cycle time reduction, SLA review, Reduced by more than 5-30 % for 93 SKUs
• Change overtime reduction, FBE was more than 480 minutes which was reduced to 210 min, Compression machine was more than 600 minutes and reduced by 220 minutes, Coating machines was more than 400 minutes and reduced by 180 minutes, packing machine was 340 minutes, and reduced by 140 minutes.
• Cost-saving more than 20 % saving v/s YOY budgeted amount –sustained
• Manufacturing capacity enhancement, Tablet 120 million to 216 million, Capsule 60 million to 90 million, Inhaler 0.6 Million to 0.8 Million
• Overall equipment effectiveness was less than 25 % which increased by 55 % and stabilized
• The lead time of SKU was earlier more than 25 days which was achieved and stabilized to 15 days
• Recognized for adequate root cause analysis, investigation, and CAPA implementation during vendor audits
• Awarded as “Shining Star of the Unit”, “Best Idea Champion “contributed with more than 55 ideas, “Best Participant” in PWI training by McKinsey (Presenting with impact), and “Best Effective Presenter/trainer” by CDSCO North Zone Ghaziabad
• Nominated as overall Change lead for SAP implementation

• Regulatory Approvals (more than 30) :

Successfully secured multiple FDA / EMA / WHO and Anvisa Approvals in India and the USA

• Strategic leadership (more than 5 Projects):

Spearheaded an Rs. 600 million green field project at Baddi / Sikkim and Multiple expansion projects.

• Operational excellence (Lean Management):

Reduced TAT for batch release by 30 % through Process optimization and team efforts

Reduced TAT for testing release by 25 % through Process optimization

Certified Master Coach by McKensie

• Regulatory expertise:

Led the submission of 5+ ANDA applications ensuring the first round of approvals and 100 % compliance with regulatory guidance.