Kamlesh Rajput

Bachelor of pharmacy with more than 22 Years experience in Production (Manager)

Baddi, SolanMember since December 30, 2025

ERPcGMP StandardsEquipment QualificationFMEAHACCPProcess ValidationComputer System Validation (CSV)DQ, IQ, OQ, PQ ExecutionFactory Acceptance Test (FAT)Site Acceptance Test (SAT)

About

Bachelor of pharmacy with more than 22 Years experience in Production (Manager). Adapt at managing the operation and maintenance of a wide range of pharmaceutical machineries and equipments in Oral Semi solid dosage form. Ensures compliance with current Good Manufacturing Practice (cGMP) standards. Capable of handling more than 100 man-power/resources.

Experience

Executive TO Manager - Oxalis Labs (Macleods Pharma) - Baddi

(2012-02)

Review and approve equipment qualification to ensure compliance with specifications and validation requirement
Conduct employee training (Through PLMS) and evaluation through on-the-job instruction and practical equipment demonstrations
Preparation and review SOPs (through DMS) for related equipment's and procedures
Raising (through ERP), review of requisition for the requirement of consumables items and check on its inventories according to their approved budget
Implementation of quality management system as per cGMP and international standards
Implementation of corrective and prevention action (CAPA) for non-conformances and self-inspection findings
To exercise affective control over environmental condition in manufacturing and other related activities which may adversely affect the product quality
To coordinate and approve calibration/maintenance of all production equipment's and instrument with engineering/QA/QC and outside agencies
To carry out routine documentation per regulatory requirements
Adhere to specified working hours
To ensure and maintain cleanliness of production area and equipment as per SOPs
Coordination with production, PPIC QC CQA, QA, Engineering and other smooth production activities
Organize the job responsibilities to the technician, officer, executive as per plan and manage absenteeism
Verification of dispensed RM/PM against production plan
Continues monitoring of in-process control in all production areas and improve daily production
To fill maintain and approve batch record online
Evaluate and sign production records before QA submission
Capable of handling more than 100 man-power/resources
Adopting latest technology in production and packing lines (track and trace system, 2D coding)
Ensuring the risk assessment for new product and existing products
Ensuring Zero non-compliance and zero data integrity in documentation
Handled change control, deviations/events, CAPA, OOS, and OOT activities through Track Wise to ensure regulatory compliance
Managed end-to-end activities across Production and Packing departments to ensure efficiency and compliance
Managed end-to-end production operations to ensure timely achievement of production targets based on rolling forecasts and availability of machines and materials
Supervised overall shop floor activities and implemented effective techniques to improve operational efficiency and achieve cost savings
Planned and optimized manpower and machine utilization through effective resource planning
Coordinated with R&D for planning and execution of exhibit batches
Conducted training activities through the PLMS system
Reviewed and authorized production and stores SOPs and work instructions, ensuring strict compliance
Ensured production records were reviewed, evaluated, and signed prior to submission to Quality Assurance
Conducted risk assessments through FMEA and HACCP to identify and mitigate process risks
Performed process variable impact analysis to assess the effect of critical parameters on product quality
Prepared, reviewed, and verified monthly WIP statements and yield reports to ensure data accuracy
Reviewed and approved manufacturing, filling, and packing protocols for Cream, Ointment, and Lotion products, along with evaluation of Process Validation reports
Ensured timely planning, execution, and compliance of qualification and validation activities in accordance with regulatory requirements
Computer System Validation (CSV) - DQ, IQ, OQ, PQ execution
Designed and implemented systems, processes (BMRs and protocols), and procedures (SOPs) to ensure smooth production operations and improve overall operational efficiency
Identified and optimized key process parameters while initiating process improvements to meet productivity and profitability goals
Performing the functions of trouble shooting and breakdown, preventive, corrective and routine maintenance for reducing machinery down time to minimum and maximum utilization of machine
Maintaining & control of consumables spare parts to facilitate smooth execution of projects
Work profile across Semi-Solid Manufacturing and Packing Departments during project execution
Conducted Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) for production and packing machinery
Managed machine installation and ensured completion of qualification documentation
Executed and documented DQ, IQ, OQ, and PQ activities in compliance with CSV and GMP requirements