HEMANTH PAVAN KUMAR KULKARNI

Project Type: Plasma facility Green field project worth 150 Cr.

• Establishment of basic Quality systems
• preparation of project schedules, coordination with internal and external teams.
• qualifications plan and execution for utilities, facility and equipment.
• handling of project documentation and trainings.

• Project support: Type of Project: Sterile vaccine facility Green field project worth1500 Cr Value for Both Drug Product (Vial Filling Lines, PFS Filling, BFS Filling Lines) and Drug Substance including Utilities, QC / Microbiology)
• Lead Team for work supervision on various activities to get quality outcome as per timelines
• Coordination with Vendors, comparison of technical documents
• Preparation of Project schedules, following up with external and internal team members
• Review of layouts against GMP aspect
• Preparation of Concept Note, Qualification Plan, Site Master File, Validation Master Plan
• Review and approvals for Vendor Documents and URS
• Participation of FATs
• Implementation of QMS System, Qualifications, Risk assessment, Training Management in to new facility.

• Managing the projects, participating on the initial technical discussions, finalization of URS, DQ approvals, FAT procedures, Site installations, Qualifications till PQ
• Handling project documentation issues in line with regulatory requirements, update as per customer requirement
• Exposure on different projects executions for Pan India Location and Overseas Project support
• Selected Contributions: Managed various projects with limited manpower due to Covid-19 pandemic restrictions
• Development of standard documentation systems in-line with especially Indian pharmaceutical industry customers.

• Handle and optimize all validation activities from initial to till handover project for commercial production
• Scope of responsibilities includes: project planning, scheduling, and tracking
• Preparation of validation documents (URS, Validation aster plan, validation development and protocols (DQ, IQ, OQ, PQ) as per regulatory requirements
• Involving in the technical activity of the product development related to quality aspects
• Selected Contributions: Successfully participated directly 8 regulatory audits for USFDA and other regulations like MHRA(Europe), TGA(Australia)
• New Equipment design based on regulatory requirements involvement on technical discussions
• Participated in various FAT representing current employers and visit to vendor sites in various counties (Italy, Germany, China) Documentation of all qualification processes and coordination with manufacturers for quality
• Manage the qualification team on successful completion of IQ to PQ along with final reports with approvals
• Providing training for the employees on Qualification and project managements related systems
• Involving in the aseptic process validation activities (Media fill)
• Preparation of SOPs, change controls, incidents – investigations etc
• Effective utilization of man powers
• Planning of work as per production schedule
• Involving in the technical activity of the product development related to quality aspects.

• Part of Production activities of Tablets manufacturing process (Granulation, Compression, Coating), Capsule Filling and liquid manufacturing operation.