curriculum vitae final sandeep
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Curriculum Vitae
Sandeep Kumar Keshari
Permanent Address: Flat No. I-3 Lilly Spring Valley Katara Hills, Bhopal (M.P.)
Mob. No.09617770755 & 09753350526 [email protected] [email protected]
Objective To work in a stimulating environment where I can apply & enhance my knowledge, skill to serve the firm to the best of my efforts.
Education M.S. (PHARMA): JAN. 2010 – DEC. 2011
Birla Institutes of technology & Science Pilani (WILP).
FIRST DIVISION WITH CGPA 8.61.
B.PHARMA: JUN. 2002 – JUN. 2006
R.K.D.F. College of pharmacy Bhopal
(Affiliated to Rajiv Gandhi Prodyogiki Vishwavidhyalaya, Bhopal).
FIRST DIVISION WITH 71.76%.
HIGHER SECONDARY: JUN. 2000 (YEAR OF PASSING) (M.P Board of Secondary Education).
FIRST DIVISION WITH 74.44%.
HIGH SCHOOL: JUN. 1998 (YEAR OF PASSING)
(M.P Board of Secondary Education).
FIRST DIVISION WITH 68.00%.
Work Experience 23rd
June 2006 – Till Date LUPIN Ltd., Bhopal, M.P.
MANAGER (M 1) – PROCESS DEVELOPMENT (PHARMA REASEARCH)
Planning, Execution and Subsequent Technology Transfer of product pertaining to regulatory and non-regulatory markets (Oral and Sterile).
Planning and execution of Pre-exhibit/Scale up and exhibit batches for
regulatory market.
Planning and execution of Process Validation for all new products for Commercial as per agreed time lines and Regulatory requirements.
Planning and execution of post approval changes for all products to meet market demand (e.g. Changes in batch size & equipments etc.) as per agreed time lines and Regulatory requirements.
Development, planning & execution of indigenous/alternative vendor of raw material and packing material.
Planning & execution of cost reduction projects.
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Knowledge of SUPAC & variation filing in regulatory market.
Management & Preparation of Batch Manufacturing Record and Batch Packing Record (Oral and Sterile) for exhibit & commercial product.
Arrangements & Review of Master Formula Cards & scale up report (Oral &
Sterile).
Arrangements & Review of Process Qualification Protocol, and their respective Reports.
Arrangements & Review of stability protocol for Exhibit (Bio batches) & Commercial batches.
Coordinate with Pharma research (R&D), QA/QC and manufacturing for providing all technical inputs for Regulatory submissions.
Arrangement and adequate availability of all relevant documents to QC/QA and RA, Leading to Technology Transform Regulatory filing and product launch.
Troubleshooting and Improvement of formulation process of regulatory and non regulatory market product from taking trial batches and conduct some
necessary in process check, such as BD, TD, PSD, Disintegration, Dissolution, and other require tests.
Handling Change control, Deviation and Quality Assurance Management
System.
Management of SAP for BMR, BPR, BOM and recipe.
Arrangements & Review of hold time protocol & reports.
Creation of product code and preparation of BOM.
Preparation & training of SOP.
Management of PDL documents i.e. Lab Note Book and Logbooks etc.
Investigation of out of specification and out of trends.
Preparation of Quality Risk Management of the existing and new product.
Dosage forms / Drug
product technology experience
Tablet (Immediate release, extended release & sustained release tablets).
Capsules (Hard Gelatin Capsules)
Dry powder for Suspension
Dry powder for Injection
Wet granulation (Rapid Mixer Granulation)
Dry Granulation (Compaction & Slugging)
Dry Mixing
Tablet granulation by matrix
Equipment Handling experience
Rapid mixer granulator
Fluid bed dryer
Roll Compactor.
Oscillating granulator & Comminuting mill
Blender
Tablet Compression
Tablet Coating
Capsule Filling
Powder filling (for Suspension & Injection)
Blister packing
Bulk packing
Project , Training & technology knows
A project on "Formulation & In Vitro Evaluation of Cefditoren Pivoxil Extended Release tablets by using different viscosity grade of the HPMC”.
Tablets Coating training in Colorcon Coating School at Colorcon Goa.
A project on "Prolong Release Medication” this project is medications for prolong
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action of drug in-patient.
Industrial training on tablet manufacturing in "Omen Drug Pvt. Ltd." (Govindpura industrial area, Bhopal).
Statistical problem solving and risk analysis.
Validation and resolving problems related to them.
Pelletization technology.
Development of new product through quality by design.
Current CTC
10.05 lakhs
Computer Proficiency Certificate of computer education by Bhoj Open University Bhopal.
Audit United State Food & Drug administration (USFDA), TGA & MHRA and various
customer audits.
Qualifying Examination GATE-2006 (Graduate Record Examination)-IIT Kharagpur
Score: 343 All India Rank: 1852 Percentile: 87.03
Civil Service Grades NCC ‘A’ Certificate.
Polio awareness programme.
Extra Curricular Won, many school level competition.
Personal Details Father name - Mr. M.P. Keshari
Mother name - Mrs. Malati Keshari
Wife name - Mrs. Poonam Keshari
Date of birth - 25th December 1983
Birth Place - Drammandganj Distt. Mirzapur (U.P.)
Sex - Male
Nationality - Indian
Marital status - Married
Language known - English & Hindi
Hobbies - Playing cricket & watching movies
Area of Interest Generic Drug Product Development
Process Development
Manufacturing
Regulatory Affairs
Quality assurance.
References Mr. Vegulla S Prasad (Sr. Manager Process Development)
Lupin Limited Pithampur Contact No. ; 09617770270
Mr. Manish Dudhani (Technical Manager - International Operations at Novartis Consumer Health). Contact No. ; 09422215314
Declaration-
I here by declare that the particular given by me in C.V. are complete and accurate to the best my knowledge.
Place-BHOPAL Sandeep Kumar Keshari