1. COVERING LETTER
Kaushal K Kishore
Radharani Apartment
Flat no. 204. Plot No. R-34
Near Club House
Silicon City, Nihalpur Mundi,
PO. Rajendra nagar, Indore (MP)
Mob: +91 8462003466
+918109235530
E-mail: kkishore20042002@yahoo.co.in
easyway2004@gmail.com
Respected Sir/ Madam
Myself Kaushal K Kishore, Science graduates with specialization in chemistry and
completed professional degree in Diploma in Pharmacy and perusing MBA in supply
chain.
Having 15 years of industrial experience in Manufacturing / packaging process of
Tablets and Production Packaging of different dosage form i.e. Non sterile,
Ophthalmic, Respiratory FFS Respules , liquid and Lyophilized sterile formulation.
And have projects experience for set up Manufacturing; filling and packaging line for
BFS technologies products i.e. sterile solution and suspension products and also
having experience of system building and process implementation in Cipla with SAP
ERP ECC 6.0 EHP 6 for Production planning , Material management and Quality
Management.
Interested to work in a reputed organization like yours. I would like to take up the
responsibilities and face the challenges from the new environs involved in the
pharmaceutical industry.
Here I enclosed my detailed resume for your perusal.
Thanking you
Yours sincerely,
(Kaushal K Kishore)
2. CURRICULUM VITAE
KAUSHAL K. KISHORE
Correspondence Address:
Radharani Apartment E-mail: kkishore20042002@yahoo.co.in
Flat no. 204. Plot No. R-34 easyway2004@gmail.com
Near Club House
Silicon City, Nihalpur Mundi,
PO. Rajendra Nagar, Indore (MP)
Mob: +91 8462003466
+918109235530
CAREER OBJECTIVE
To grow in a conducive environment exploiting my domain and potential to the fullest
extent to attain the ultimate goal of the organization where I can prove my caliber
and nevertheless to be a good team leader.
PERSONNEL SKILLS
Comprehensive problem solving abilities, excellent communication skill, honest and
Trustworthy good Attitude around others. Willing to help, patient with people, willing
to learn, self-confidence & amp; utter devotion towards responsibilities.
CAREER PROFILE
Total 15 years of experience in manufacturing/Packaging process of Tablet and
packing process of different pharmaceutical dosage forms.
3. SNAP SHOT OF EXPERIENCE
PERIOD POSITION ORGANIZATION
Dec.2010
to till date
Management Staff Production
(Working as a FFS Packing Head
and projects head) In FFS
department for Ophthalmic and
Respiratory products I.e. Eye drops,
Respules and UD containers.
Cipla Ltd. Indore SEZ, Regulatory
Facility approved from USFDA,
MHRA,TGA ,WHO,ANVISA
Equipped with latest GMP model
imported machineries for Paraentraral
(Ophthalmic, LVP Injection) and
inhalation products.
August
2007 to
Dec.2010
Sr. Executives production
(Packaging) Cyto/noncyto toxic
Tablet, Capsule, Cytotoxic
Injectable.
Dabur Pharma limited Baddi,
(Presently Fresenius Kabi oncology
Ltd.) Himachal Pradesh. MHRA,
USFDA, ANVISA, MOH –Canada,
MCC-SA Approved facilities for
tablet/capsule, Injection (Liquid /
lyophilized products).
January
2006 to
August
2007.
Executive production (Packaging
ophthalmic preparation)
Nicholas Piramal India Ltd. Pithampur,
An USFDA Approved Plant for non-sterile
products.
August
2003 to
January
2006
Production (Packaging) Sr.
Officer in Tablet/Capsule.
Ipca Lab. Ltd, Athal (Silvassa).
Formulation facility at Athal is approved
by MHRA, MCC, TGA, WHO-GMP
Geneva, ANVISA (Brazil) & AN ISO
9001 Certified company.
March 2001
to August
2003
Production Chemist in Tablet
Section.
Mercury Laboratories Ltd., Baroda
Gujarat.
WHO GMP & ISO 9001 Certified.
4. CAREER ACHIEVEMENTS
Production department team Leader during successful audit faced for:
• USFDA
• MHRA
• USFDA
• WHO (Geneva & Local)
• TGA
• INVIMA, (Columbia)
• ANVISA (Brazil)
• Hungary….. etc.
Involved in the core technical team, successfully completed facility, equipment
qualification and process validation of different products.
Successfully & Independently Executed WHO Geneva and Local, Mock and final
USFDA, MHRA, TGA, ANVISA, MOH-MAXICO AND KOREAN etc. audit from
packaging production.
Successfully handled the project of Dabur Pharma Ltd. Kishanpura, Baddi
(Oncology Plant).
ANDA Product and Oncology Product Handling.
Successfully system designing and Material Master building for launching SAP
ERP System with latest 730 final release version 7300.1.3.1079 in Cipla
formulation and API plant in one Go.
Worked as central core team member for implementation for PP-PI, QM and MM
Module in global Cipla.
Building system based on “As Is” and “To Be” process mapping and developing
system for generation of mfg. and packaging batch documents from SAP
system.
5. End users training and Post Go live support to entire formulation plants.
Working on track and trace and Bar code projects from dispensing of
API/RM/PM to product execution at shop floor and synchronizing with EMBR/
EBPR.
Currently working for projects of BFS technologies technology transfer of 09
products from Finland and own products Budesonide Suspension respiratory
respules for USA market.
MY STRENGTHS:
Improvise in difficult work conditions. Having good interred personal skills.
Good team building and training capabilities.
Self-motivated, flexible and forward thinking.
Ability to learn advanced technologies faster.
Ability to work harder and smarter in a team.
Ability for team building and focused approach
6. CURRENT JOB RESPONSIBILITIES
Technology transfer for the 08 Unit dose and 01 Multi dose FFS containers eye
drops from Santen, Finland facility to Indore site and working on Projects for
new FFS line set up for Budesonide suspension respiratory respules for US
market.
Santen Manufacturing site and Indore site evaluation for technology transfer of
all the 09 products for US, Europeans and Russian’s markets.
Central point coordination for the Production/ packaging activities with the
Santen, Finland and other internal stake holder.
Vendor evaluation for new machine procurement, process development and
Performing GMP audits.
Project Handling, Equipment Ordering, Party Negotiation, FAT activities.
Planning, scheduling the production and packaging activities and trouble
shooting.
Responsible for manufacturing, filling and packing activities for feasibilities and
registration batches for Santen, Finland product transfer.
Documentation ( Qualification & validation protocol preparation and execution,
SOP, Batch documents and other relevant GMP document preparation and
review for implementation.)
Communication with the supporting department Like QA, QC, HR, R&D, Store
and Maintenance.
Responsible for Work safety in the dept.
Responsible for Audit/Different Countries Visit requirement.
Inter departmental Auditor i.e. Self Inspection team member to maintain the
existing system as per cGMP norms and to improve the system as per
regulatory requirement.
Manpower arrangement in shift & planning for Shift & general Management.
Certified Trainer to giving Training for associate’s workmen, Engineer, Officer
cGMP/all related document, Equipment and Process requirement of Production,
Packing, Store and Water System.
7. Actively Project handles for installation and Commissioning of all production
and Packing Equipment, Qualification and requalification of Optical
inspectors.
Fulfill Regulatory requirement and involve with R&D Person for ANDA and
Europe Pre-exhibit, and Exhibit Batch Technology Transfer.
Setting of critical products and its validation.
To monitor the site transfer projects and performs process validation, process
development activities. To assess equipment suitability and perform Quality risk
analysis and (FMECA) Failure mode effect critical analysis during various stages
of process and equipment validation.
Indore formulation Site trainer for the SAP ERP system and process support and
trouble shooting in PP, QM and MM modules process.
SKILLS
Technical:
Working Experience in Production (Packing)
Manufacturing and packaging of Tablets, Packaging of Capsule, Ophthalmic
preparation, Respiratory solution, Liquid and Lyophilized Injectable Oncology
formulation.
Involved in the Installation & commissioning of Equipment. Validation of area,
process & equipment in Dabur / Fresenius Kabi Oncology, baddi and Cipla ltd.
Involved in production planning scheduling and execution of
production/packaging of different products as per the marketing demand and
meet the customer OTIF.
Utilize the available resource to it maximum extended and increase machine
efficiency.
Trouble shoot out of packing machine problem and reduce the break down
hours.
8. Continual improvement of packing technology and atomization for better
operation and controls.
Production planning, scheduling and MRP in SAP for better and transparent
business flow.
Designing and Development:
Execution of facility, equipment qualification, process and cleaning validations
activities as per the approved protocols.
Assisted R & D in new products development and existing products process
improvement.
Non-Technical:
Involved in the area of preparation, Technical and Data integrity training and
implementation standard of procedures (SOPs) and cGMP norms.
Exposed to the following corners of quality management system documentation
practices; Change control procedures, deviations, CAPA, FMECA and cross-
functional investigations.
Identification of KPI’s and preparation of effective action plan to achieve the
maximum OEE for a bottle neck machine in a synchronized line, to improve the
OEE of entire line.
Budgeting for the departmental expenses and inventory of new machine, new
tooling and spare parts.
Implementation of new development with the coordination of corporate
Technical team and vendors for better atomization and develops effective
control in lines.
Develop better coordination with inter departmental (supporting departments)
and with Top management for smooth and effective working environment to
achieve the management goal.
9. Approvals and Memberships:
Have got Approval in manufacturing of Tablet as “Approved Chemist”
Registered Pharmacist by Bihar state pharmacy council, Patna.
COURSES ATTENDED
Undergone various e-learning trainings as per the corporate program at Mecury
lab. , IPCA lab. Ltd., Nicholas Piramal India Limited, Dabur Pharma Limited
(Fresenius Kabi Oncology Limited) and Cipla Ltd.
Attended External Faculty various trainings regarding regulatory audits
preparation, cGMP, personality development, Validation Program, (TQM) Total
Quality Management training.
Undergone quality, safety, Fire Fighting and environment monitoring training
programs, Personality development and attain various work shop for effective
communication.
Having get training on effective communication and presentation skill.
SAP ERP training and system mapping as a core team member in Formulation
Production planning by Accenture and SAP AG Germany for 1.8 years.
Training on track and trace, Bar code procedure and electronic batch
documentation.
10. ACADEMIC QUALIFICATION
COURSE
COMPLETED
BOARD / UNIVERSITY Division
Diploma in Pharmacy Govt. of Bihar State Health and
Medical Education.
Ist
Bachelor of Science
(Chemistry) Honors
Magadh University , Bodh Gaya
Ist
Intermediate of
science.
BIEC Patna-01
Ist
Matriculation ( 10th
) BSEB Patna-01 IInd
Perusing MBA in production management and product chain management.
COMPUTER PROFICIENCY
• Platforms (OS): Windows 95, 98, 2000, 2013, XP, Window
• Applications : MS Office (Microsoft Word, Excel, Power Point Presentation,
Internet concepts.
• Competency in Information technologies projects execution for process
industries.
HOBBIES
Reading Books/News paper, listening classical music’s and Playing Outdoor games.
PERSONAL INFORMATION
11. Date of Birth : 28th Feb. 1972
Sex : Male
Marital Status : Married
Languages Known : English, Hindi, Bengali and Guajarati
Passport status : Available
Nationality : Indian
Present salary : 12.5 Lac / Annum.
Expected salary : Negotiable
DECLARATION
I hereby solemnly affirm that all the information furnished by me is true to the best of
my knowledge. If given a chance, I assure you that I will prove myself as an asset to
your organization.
Sep.2016
Place: Indore (KAUSHAL.K.KISHORE)