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[QUOTE=Guest-IJT;150596][b]Name [/b]: Santosh Kumar
[b]Email [/b]: monu1176 AT yahoo.com
[b]Designation / Skillset[/b] : Assistant manager Technology Transfer
[b]To [/b]:
The Personnel Manager,
[b]Subject [/b]: Project management for New Product Technology Transfer.
Respected Sir,
 Being given to understand from reliable sources that there are certain. I hereby have vacancies for the above mentioned post to be filled in your esteemed organization the honor to apply for the above post, with my resume which is enclosed for your kind perusal.
I would be most obliged, if I am considered for the above mentioned post requirement. and I am confident that after going through my resume it would definitely satisfy your I assure you that if I am selected I will discharge the duties entrusted to me to the entire satisfaction of my superiors.
Thanking you and trusting that my application will receive for favorable consideration at your hand.
 
Thanking you
Your’s Faithfully
Santosh Kumar

[u][b]Resume[/b][/u] :
 
 ACADEMIC DETAILS 
School / Collage Year of passing Division
H.S.E. (10th) 1992 1st
C.H.S.E (10 + 2) 1994 1st
B.Pharm
(Sambalpur university) 1999 1st
[b]Computer knowledge  [/b]: WINDOWS XP, MS OFFICE XP, COBOL SYSTEM, Foxpro, ERP
[b]FDA approval  [/b]: Approved in tablet manufacturing from silvassa (D&NH).
SELF DEVELOPMENT 
[b]Undergone Training program  [/b]:
- Program “cGMP Requirement in pharmaceuticals manufacturing” by Mr. Asrani.
- ISO training conducted by Dr. B.M.Sharma (ISO consultant)
- MCA, MCC, TGA & USFDA guidelines.
- Trained the trainer.
- Role of auditor.
- Requirement of regulatory market.
- Area qualification
- Building commissioning
- Site Master File.
- Dossier/Drug Master File.
- Validation activity and Training.
- Role of Guidelines in Pharmaceuticals Industry.
- Total Quality Management system.
- Quality Management system.
- Handling of Change Control, Deviation.GMP Non Compliances for Regulatory Markets.
 
[b]WORK EXPERIENCE [/b]: 
 
1. Sandoz Pharmaceutical Ltd. (Kalwe)
[b]Plant approval  [/b]: USFDA, MHRA, MCC & TGA approved plant.
[b]Manufacturing of  [/b]: Pharmaceuticals solid oral dosage form.
[b]Designation  [/b]: Assistant Manager Technology transfer in production department
[b]Duration  [/b]: From 06th Nov 2008 to till date
[b]Major Roles and responsibilities  [/b]: Project management for New Product Technology Transfer from Development & Other Manufacturing site to full scale production:
- Project Management of various pharmaceuticals dosage forms with large cross functional teams.
- Project Costing for Tech-Transfer and Developments.
- Project allocation to transfer team.
- Work with Plant, SCM, R&D, QA, and RA to execute contracts to ensure product delivery as per service level agreement with client in terms of quantity, quality and agreed time frame.
- Control overall technical scope, project costs & timelines, escalate potential challenges like capacity/resource constraints, delays, cost overruns, Assess new investments required with technical/financial analysis and implementation plan, Cost & Operations efficiency improvement.
- Ensure HSE assessments for each new product before feasibility / Trial batch.
- Ensure Manufacturing license availability for each new product.
- Ensure Cleaning risk assessment on time for each new product.
- Ensure sufficient Hold time to be available at receiving site for all transfer products.
- Ensure Successfully scaling up the drug from discovery to market introduction
- Implementation of cost/process improvement initiatives.
- Overseas exposure for the business discussion, gap analysis of two site and technology absorption.
- Ensuring that available resources are used in the most effective and efficient manner.
- Giving technical inputs for proposal viability , Agreement
- Monitor Budget v/s actual performance, profitability, Forecast, Project plan and Contracts Management.
- Review of timeline status for project completions.
- Review the technical dossier, master BMR, validation protocol.
- Identify opportunities for developing new business with existing customers and develop the road map for the same.
- To provide the update of the project to Client and senior management through weekly call, meetings.
- Prepare Task Break Structure, time lines and manage assigned projects , Track man hours and Equipment hours for each project
- Handling the logistic issue for the delivery with planning team.
- Responding technical query to client with interacting with several cross functional team.
- Coordination for licensing, for Importing, the Narcotic API & FG.
- Coordination with business development team to process product requirements and prepare cost proposals with input from Plant / R&D.
- Coordinate activities to support procurement of all finished dosage components, active & inactive ingredients, labeling, packaging, & other related components.
- Identify opportunities for investment in new technologies, plant assets, and new product class and develop the road map for the same.
[b]Exposure in Production [/b]:
[b]- Exposure in granulation [/b]: Rapid mixer Granulator, Fluidized Bed Dryer/processor, multimill, vibrosifter, blender, Dry/wet Granulation.
[b]- Exposure in Compression & Encapsulation [/b]: Cadmach, Fette-2020 & Legasy-6100, PAM PACK capsule filling machine.
[b]- Exposure in Coating [/b]: Gans-coater.
[b]- Exposure in packing [/b]: Blister PAM pack machine & Strip pack machine.
[b]- Exposure in Injectable [/b]: Vial washing machine, Autoclave, Tunnel, filling and sealing machine.
- All production Equipment validation.
[b]Exposure in QC [/b]:
- RM / FG/ Stability / Micro Analysis & documentation practice in QC.
- Instrument Handle; HPLC LC20101C (Simadzu), U.V. (Simadzu, Jasco), GC with head space (Simadzu), FTIR (Simadzu, Jasco),
 
2. Emcure Pharmaceutical Ltd. (Pune).
[b]Plant approval  [/b]: USFDA,TGA, MHRA & MCC approved plant.
[b]Department  [/b]: Tablet, capsule, Injectables and packing.
[b]Designation  [/b]: Assistant manager R&D and Tech-transfer Department
Duration : From 05th May 2006 to 30 th Oct 2008
Role and responsibility : - Over all Responsible for Tech-transfer Department at R&D.
- Gap analysis between two different manufacturing sites for various dosage forms.
- To evaluate the facility for back up site manufacturing and change of site of manufacturing of different dosage forms at various locations.
- To review the technical dossier and prepare master BMR, validation protocol.
- To execute the pilot scale trials & pre-validation batches of different formulations (tablet, injectable).
- Documentation: Preparation of Batch Manufacturing Records, Process Validation Protocols, Reports and seek approvals from the QA authorities of International sites.
- Review and approval for QC specification and follow up for Analytical Method Transfer as well as Artwork development for packaging material.
- Manufacturing of full scale Validation batches (Technology Transfer) at site.
- URS for major machine, identification of Supplier, FAT for new machine
- A team member for the purchasing of equipment’s & machineries, Installation and Commissioning assistance for new Project
3. TORRENT PHARMACEUTICAL LTD. (INDRAD).
Plant approval : MHRA & MCC approved plant.
Department : Tablet, capsule, Injectables and packing.
Designation : Executive Quality assurance (Tech-transfer Department)
Duration : From 05th April 2005 to 30 th April 2006
Role and responsibility : - To Execute Quality Assurance Tech-transfer Department.
4. ALKEM LAB. LTD.
Plant approval : MHRA & MCC approved plant.
Department : Tablet, capsule, Injectables and packing.
Designation : Executive Quality assurance
Duration : From 19th April 2004 to 27 th July 2005
Role and responsibility : - To Execute Quality Assurance Department.
SANTOSH KUMAR
 
5. SUN PHARMACEUTICAL LTD.
Plant approval : WHO, ISO approved plant.
Department : Tablet, capsule and packing.
Designation : Sr. Officer Quality assurance
Duration : From 3rd July 2001 to 18th April 2004.
Role and responsibility : - To supervise Quality Assurance /Quality Control Department.
6. INDICHEMIE HEALTH SPL.PVT.LTD. 
Plant approval : WHO approved plant.
Department : Tablet, capsule and packing.
Designation : Officer Quality assurance
Duration : From 22nd April 2000 to 2nd July 2001
Role and responsibility : - To supervise Quality Assurance /Quality Control Department
7. NESTER PHARMACEUTICAL LTD.
Plant approval : WHO approved plant.
Department : Tablet, capsule and packing.
Designation : Chemist QC/QA
Duration : From 14th April 1999 to 22nd April 2000.
Role and responsibility : - To supervise Quality Assurance /Quality Control Department
The above finished details are true and correct to the best of my knowledge
Thanking you,
Yours Truly,
Santosh Kumar
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More Information about this submission and submitter:-
___________________________________________________
Submission ID : 4369592
Date & Time : 14th Jul 2011 6:46 AM (UTC)
IP Address : 160.62.13.190
Browser Info : Mozilla/4.0 (compatible; MSIE 8.0; Windows NT 5.1; Trident/4.0; SV1; .NET CLR 1.1.4322; .NET CLR 2.0.50727; .NET CLR 3.0.4506.2152; .NET CLR 3.5.30729; MS-RTC LM 8)
Predicted Country : Singapore[/QUOTE]

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