OBJECTIVE:
To become a part of innovative and challenging environment where my knowledge of Chemical engineering can be applied, shared and enriched, enabling me to develop personally and professionally in turn contributing to the growth and progress of the organization.
ACADEMIC PROFILE:
Qualification
Institution
Year of Completion
Percentage
Class
B. Tech Chemical Engineering
Anna university
2010
62.0%
First Class
Diploma in Chemical Technology
Start Board of Technical Education
1999
75%
First Class
TOTAL YEARS OF EXPERIENCE: 22+ years of experience in new molecule scale up, Technology Transfer, Operation excellence, Bulk Scale Manufacturing activity of Intermediate, API. Handling & Good Exposure in Size reduction activity by using varies automated Equipment in Powder Processing area with Bulk Quantity of API in Pharmaceutical Industry. Currently working as M/S Kawman pharma ltd, Senior Manager in Production department possess expertise in Process Optimization, Operations, planning and execution of new and commercial projects.
CAREER SNAPSHOT:
S. No
Name of the organization
Designation
From
To
1
Kawman Pharma Limited
Cuddalore
Senior Manager – Production
Nov-2023
Till Date
2
Aurobindo Pharma Limited
Visakhapatnam
Manager – Powder Processing Area
April-2019
Nov-2023
3
Aurobindo Pharma Limited
Visakhapatnam
Deputy manager
June-2015
April - 2019
4
Primal Enterprises limited Chennai
Manager
April-2012
May-2015
5
Primal Enterprises limited Chennai
Senior Executive
June-2011
April-2012
6
Actavis Pharma Manufacturing Private Limited,Chennai
Officer
February-2007
March-2011
7
Sanmar specialty chemical limited, Chennai
Chemist
November-2005
February-2007
8
Malladi drugs and pharmaceutical limited
Junior Officer
Setember-1999
November-2005
ORANIZATIONAL EXPERIENCE OF POWDER PROCESSING OPERATION IN AUROBINDO PHARMA LIMITED
Handling of multi Product facility API Clean Room and Powder Processing area from June-2015 to
Nov 2023
Handling of Bulk Quantity (20 Tons to 60 Tons per Month) of on line automated closed loop Powder Transferring system of Size reduction, sifting, Blending and packing activity.
Prepare the Production planning based on marketing demand and Customer Specification.
Based on the customer requirement of Particle size and Bulk Density specification assign suitable size reduction Equipment (Pin Mill, Micronizer, Air jet mill) to validate the Process and optimize parameter for Commercial Production.
Customer required the narrow range of Particle size and Bulk Density specification, Big challenging to reduce the Particle size and assign suitable size reduction Equipment to optimize parameter and validate the Process for Commercial Production.
Clean room handling and keeping the area as per the cGMP requirements and putting continuous efforts for improvement in quality.
Handling of Higher Batch size (1000 to 1340 Kg) of filtration cum drying operation in ANFD or Drying operation in RCVD, RVPD, Vacuum Tray drier and tray discharger. Size reduction equipment of Co Mill, Pin Mill, Micronizer, Air jet mill and Maintain the area as per the cGMP requirements and putting continuous efforts for improvement in quality.
Handling of ERP system for Raw material procurement and stock verification of intermediate and API production stock and PR raising and intending of consumables.
CURRENT JOB RESPONSIBILITY:-
Prepare the yearly base line plan and quarterly production plan, Raw material & Packing material requirement based on market demand, Equipment availability and product cycle time of various products by considering Monthly & Annual Preventive maintenance of equipment, periodic cleaning and AHU Periodic validation.
Planning & Executing the Prevalidation, Process validation & cleaning validation of the equipment as per the cGMP guidelines of new products.
Responsible for maximize the production and to meet production targets.
To execute the all cost improvement program before commercial scale Production. (Recovery solvent Recycle, By Product,Spent solvent Recovery)
Scale up of new products from R&D to pilot plant to commercial scale
Handling manpower, resolving issues, team building, training and development of Operating personnel and subordinates.
Handling of 75 People in Production.
Handled Low Volume High Cost products in Kilo lab/Pilot plant.
Coordinate with project team to commencing of new facility as per the process requirement
Handing Training logs, Deviations, Investigations, CC, CAPA, OOS and OOT.
OOS, OOT and Deviation analysis through 7 Qc Tools of FMEA to identify the route cause and CAPA. Responsible for implementation of corrective & preventive measures within the time line and monitoring the CAPA effectiveness.
Manpower management like selection, appraisal, deployment and their growth.
Handling of all regulatory, customer and safety audit for my plant as a subject matter expert with zero noncompliance.
USFDA audit involved and completed successfully July –2022 in Aurobindo pharma limited. Unit11.
Equipments Handled: Reactors (AGR, GLR, SSR & HSR (Capacity: 10 L to 25 KL), Centrifuge, Filters (Nutsche, Sparkler & Buchner Filter), Driers (RVPD, RCVD & VTD), Size reduction Equipment (Multi Mill, Pin Mill, Air Jet Mill, Micronized) and Sifter.
DOCUMENTATION:
Preparation and Review of new BMR (Batch Manufacturing Record) and GCR (Generic Cleaning record).
Preparation/Review of all SOP (Equipment, Cleaning, General SOP etc.).
Review the Process risk assessment and impact assessment.
Involved in HAZOP meeting for new products and Scale up.
Planning & executing the Trial, Process validation & cleaning validation of the equipment as per the cGMP guidelines of new products
Following cGMP Standard and monitoring the critical process parameter Regularly to prevent failures and ensure 100% FTR
Undertaking regular inspections to prevent accidents and Hazard occurrences.
Following the process Safety in the shop floor to bring the behavioral changes by conducting the safety contacts (addressing good practices, unsafe practices & getting the commitment)
CAREER ACHEIVEMENT:
S .No
Name of the award
Purpose of award
Company Name
Year
1
Lean-Sigma project
Production Capacity Enhancement of Levetiracetam API 40 Tons to 60 Tons
Aurobindo pharma limited
2021-2022
2
DMAIC Project
Levetiracetam API Yield increased from 96 to 98.88 %
Aurobindo pharma limited
2022-2023
3
Best achievement Award
Identify the Process Gap as per in BCPR or SOP to discuss with concern department shall be in line with our procedure.
Aurobindo pharma limited
2020-2021
4
Best KRA and LDM Award of Block
Three times Achieved the Best KRA and LDM Award of Block.
Aurobindo pharma limited
2022-2023
S .No
Name of the award
Purpose of award
Company Name
Year
5
Spot on award
Simplifying process
1. Identified the root cause of impurity formation R- Enantiomer in Levetiracetam API.
2. Time cycle and handling loss of product reduced in filtration process of Levetiracetam API.
3. Particle size reduction to achieve the required particle size for Levetiracetam API & Emtricitabine API
Aurobindo pharma limited
2015-2016
6
Energy Conservation reduction and cost Reduction
Identify the Possibility to reduce the Energy conservation of power, steam and water consumption.
Aurobindo pharma limited
2022-2023
7
SFTI (Shop Floor transformation initiative) Silver Level award
Lead of SFTI activities daily to tracking the quality, safety and health to monitoring the KPI to achieve the target.
Piramal Enterprises limited
2013 to 2014
8
Campaign Based best Product achievement award
Successfully completion of the CRO campaign based Product with Stipulated time line given in the RFP
Piramal Enterprises limited
2014 to 2015
PERSONAL SUMMARY
Father Name : D. Rajiv Gandhi
Date of Birth : 05/06/1981
Language Known : Tamil, Telugu & English
Notice period : 3 Months
Address : No: 136 New Door No: 313
Balagangadara Street, Adambakkam,
Chennai: 600088.
DECLARATION
I hereby declare that the above-furnished details are true and correct to the best of my knowledge and belief.
Date:
Place: Chennai (D. Rajiv gandhi )