Vijay Kumar

Results-oriented Pharmaceutical Manufacturing Operations Leader with over 10 years of comprehensive experience specializing in pharmaceutical pellets manufacturing, coating technologies, and production facility management. Demonstrates deep practical expertise in drug-loaded pellets, sustained-release (SR) formulations, and enteric-coated pellets systems. Recognized for hands-on mastery in Fluid Bed Coater (FBC), Wurster coating technology, drug layering, seal/sub-coating, and Extruder-Spheronizer and granules techniques.

A strong cross-functional communicator with a proven track record of orchestrating end-to-end production operations through seamless coordination across PPIC, Warehouse, QC, QA, R&D, Engineering, and Sales departments.

Prior Quality

Assurance (QA) background provides an exceptional foundation in cGMP compliance, SOP development, deviation investigations, change control management, CAPA implementation, and audit readiness. Adept at driving technology transfer, scale-up execution, process validation, and manpower utilization.

Production Manager – Pharmaceutical Pellets - Rashmi Pharma Pvt. Ltd.

10 Years

• Production Planning & Operational Scheduling: Formulate and execute daily, weekly, and monthly master production schedules in close communication with PPIC and Warehouse departments, achieving 98.5%+ average batch yields and improving on-time batch completion.
• Pellets Manufacturing & Coating Operations: Manage day-to-day production activities for drug-loaded, sustained-release (SR), and enteric-coated pellets manufacturing, utilizing Fluid Bed Coater (FBC) and Wurster technology systems.
• Extruder & Spheronization Development: Operate and optimize Extruder and Spheronizer equipment for pellets preparation, matrix formulation execution, and process development activities.
• Process Parameter Monitoring & Control: Continuously monitor critical process parameters including inlet air temperature, product bed temperature, airflow rates, spray rates, atomization air pressure, and coating weight gain percentage.
• Technical Troubleshooting & Root Cause Analysis: Systematically identify, investigate, and resolve complex process issues including spray gun/nozzle blockage, pellets agglomeration, sticking, uneven coating thickness, color variation, and dissolution rate deviations, reducing unscheduled equipment downtime by 20%.
• SUBA Granule & Advanced Formulations: Execute and scale up Super Bioavailable (SUBA) granule formulations and specialized pellets delivery systems from R&D scale to commercial production lines formulations.
• Process Validation & Documentation: Prepare, review, and execute process validation protocols, BMRs/BPRs, and technical support reports, maintaining a 100% first-pass regulatory compliance rate during internal and external quality audits.
• R&D, Scale-Up & Technology Transfer: Plan and review R&D trial activities, participating in process optimization, scale-up, technology transfer protocols, and the adoption of improved manufacturing best practices.
• Quality Deviations & CAPA Execution: Support deviation investigations, perform thorough root-cause analysis (RCA), and implement corrective and preventive actions (CAPA) to maintain product quality and process consistency.
• Cross-Functional Departmental Coordination: Lead multi-departmental coordination across Production, PPIC, Warehouse, QC, QA, R&D, Engineering, and Sales to ensure smooth workflow execution from raw material staging to final release.
• QC, QA & Sales Dispatch Alignment: Coordinate with QC for timely sample submission and analytical result tracking, while liaising with QA and Sales for batch release clearance and finished-product dispatch planning, shortening dispatch turnaround by 2 business days.
• Manpower Allocation & Safety Compliance: Lead production technicians, operators, and contract workers, managing shift allocation, training, and strict adherence to SOPs, cGMP guidelines, and industrial safety standards.

QA Executive – QC/QA - Rashmi Pharma Pvt. Ltd.

• GMP Documentation & Verification: Managed day-to-day cGMP document verification, reviewing 100+ BMR/BPR records, logbooks, and batch records to ensure full compliance with regulatory standards.
• SOP Preparation & Implementation: Authored, reviewed, and implemented Standard Operating Procedures (SOPs) across manufacturing, quality control, and warehouse operations.
• Quality Systems Management: Handled Change Control documentation, deviation tracking, and investigation support in coordination with manufacturing teams.
• Market Complaints & CAPA: Supported investigation of market complaints, root cause identification, and implementation of effective CAPAs within target timelines.
• Vendor Qualification & Audits: Participated in vendor qualification activities, raw material quality evaluation, and vendor audit documentation support.
• Method Validation & Cross-Department Liaison: Compiled method validation records and acted as a primary liaison between Production, Quality Control, and Quality Assurance departments.

Master of Pharmacy (M.Pharm) - Pharmaceutical Analysis & Quality Assurance - Bomma Institute of Pharmaceutical Sciences (Affiliated to JNTUH) (2014)

Bachelor of Pharmacy (B.Pharm) - Pharmaceutical Sciences - Prathishta Institute of Pharmaceutical Sciences (Affiliated to JNTUH) (2012)

Intermediate (Bi.P.C) - Government Junior College / Private Campus (2007)

S.S.C - Secondary High School (St.Joseph’s high school rudrampur kothagudem. (2005)