Dr. Alok Kumar Sharma has over 23 years of experience in manufacturing operations and quality assurance in the pharmaceutical bulk drugs industry. He holds a PhD in Organic Chemistry and has worked in leadership roles at several companies, currently serving as Vice President at Kores India Ltd. He has expertise in production planning, quality management, process optimization, and commissioning new plants and products.

1. DR. ALOK KUMAR SHARMA
E-2103, Sunflower,Neelkanth Greens,Manpada Ghodbunder Road,
Thane-400610, Maharashtra
Ph: +919819691657
Email: alok18_sharma@rediffmail.com, alokalpana2004@yahoo.co.uk,
I am Eligible for senior management positions in Manufacturing Operations/ Quality Assurance
with a progressive organization of repute, preferably in Pharma Bulk Drugs Industry.
Educational details
Examination Year Main Subjects Division
Secondary school examination 1975-76 Physics, chemistry &
Maths
First (Distinction in
chemistry)
Higher secondary school
examination
1976-77 Physics, chemistry &
Maths
First ((Distinction in
chemistry)
B.Sc( Three years degree ) 1977-1980 Physics, chemistry &
Maths
First
M.Sc ( Organic chemistry) 1980 to 1983 Organic chemistry
(Specialisation)
First division ( Stood 4th
in
university )
Ph.D (Organic chemistry) 1983 to 1988 Topic: Thiophene and
sesquiterpenoids,
isolation
characterisation and
synthesis of some
derivatives
Degree was awarded in
1988 after examination of
thesis and interview by one
of the top scientist of India
Dr.Nityanand ( Director of
Central drug research
Institute)
PG diploma in RA(API) 2015-16 ICH,CTD,Impurities,
stability,EU and US
submissions,AVM,etc
73%
PROFESSIONAL PROFILE
 PhD in Organic Chemistry with over 23 years rich experience in production, plant operations,
process improvements, quality control in pharma / bulk drugs industry.
GSK -1989 to 2003
Hands On experience of running a plant ( 200 reactors), Compliance with cGMP and group policies
and procedures, Process optimisation, commissioning of new products, commissioning of new plants
, Establishing quality systems with QA and implementation, cost reduction, MIS reporting ,
secretary of technical committee of the technical operations of the site,HAZOP, Risk analysis ,
training validations SOP writing etc, In absence of factory manager , coordinating the activity of
the factory.
 A keen planner with profound expertise in developing and effectuating production & quality
plans, providing quality guidelines for achieving top-level performance levels.
 Proven ability of spearheading capacity enhancement projects; achieving significant cost
reduction.
 Keen understanding of safety and GMP aspects.
 Demonstrated competence of setting up processes for commencement of Clobetasol,
Clobetasone and Beclomethasone production.
 Experience of handling production of bulk drugs such as:
 Vitamin A,
 Trichlor Phos,
 Calcium Sennosides,

2.  Acid Sennosides,
 Methdilazine Hydrochloride
 Betamethasone,
 BetamethasonedisodiumPhosphate,
 Clobetasol
 Clobetasone
 Beclomethasone
 Betamethasone valerate.
 Sertraline Hydrochloride
 Cefiximetrihydrate,
 Cefpodoxime proxetil,
 Cefuroxime axetil,
 Ciprofloxacin
 Glyclazide
 Glimiprride
 Metformin
 Cefdinir
 Oxfloxacin
 Citalopram
 Escitalopram
 Ondansetron
 Sodium Chromoglycate
 Oxytetracyclene hydrochloride
 Flunixin Meglumine,
 Enalapril Maleate (COS)
 Telmisartan
 Pregabalin
 Theophylline
 Etofylline
 Doxofylline
 Ambroxol
 Ivabadine
 Rosuvastatin
 Dorzolamide
 Montelukast Sodium
 Ivabridine Hydrochloride
Type of various reactions handled
Gridgenard Alkylation
using diazomethane
Gardener oxidation Bromination
Hydrofluoroation phosphorylation Reductions with NaH Enzymatic hydrolysis
Hydrogenation Fermentation Esterification Friedel craft
Jone’s oxidation Fermentation plant
and culture lab
Nitration reaction Low temperature
(-400
C) cyrogenic
reactions
 Excellent relationship management and communication skills.

3.  Played a key role in exalting capacity levels of the following:
- Betamethasone plant by from 1800 kg per annum to 2650 kg per annum and further
balancing capacity to 3.5T per annum. This capacity expansion saved a lot of expenditure.
 Recycled recovered solvent at a quality critical stage, thus saving costs.
 Reduced usage of high value catalyst which brought down the cost substantially.
 Pivotal in handling removal of foreign impurities from finished API through location of cause of
physical contamination.
 Single handedly completed Perfect Supply Model Project, which involved comparison of
company business with that of competitors in terms of quality, compliances, costs, safety
measures etc.
 Spearheaded commissioning of Clobetasol, Clobetasone and Beclomethasone processes at
commercial level.
 Achieved significant cost reduction through reuse quality critical solvents in Betamethasone and
also reduced occurrence of hazards.
 Process validation of 21 stage chemical synthesis.
 Written technical packages for various products and processes.
 Technology transfer/ receiving.
 Trouble shooting.
Norbrook : 2003 t0 2004
• Capacity expansion of one of the API
• Commissioning and operation of computer controlled solvent recovery plant
Saurav chemicals :2005
• Commencing the commercial production
• Solving the technical problems of hydrogenation reaction of sertaline hydrochloride
process.
• Qualification process of equipment including HVAC
• Writing SOP’s and implementing quality systems.
Sdfine chemicals :2006
• DQ/IQ/OQ of facility
• Qualification of SCADA system and documentation.
• Developing and optimising some of the molecules for other parties (process development)
• Documentation system for the facility (Operating procedure)
• Plant administration
• Chairman of safety committee.
• Technical discussions with consultants and the plant engineers and implementation of
the project related activity
• Regular production activity (although the plant was not fully loaded)
GULF Oil corporation(WHO certified(2007 to2009)
• cephalosporin production
• Capacity planning
• COS for EDQM
• Responsible for factory’s commercial production and administration
• Recently factory has been inspected for WHO-GMP
• Process of quality management system implementation is on now.
• Currently engaged in stabilising the new products and technical aspects of the process.
• Just started the cleaning validation master plan and work is going on.
• Cleaning validation master plan

4. Biocon Ltd: Head of operations.(2009 to 2010)
• Setting –up the factory
• Recruitment and coordination with Statutory bodies
• Responsible for Factory P&L
• Responsible for product commissioning and commercial production.
Kores India Ltd.(2010 to present)
Currently I am working as vice president with Kores India Ltd. The business involves APIs and
advanced intermediates.
Current Organogram
1. 20 million USD
2. 250 employees
3. Technical and commercial operations of the division.
4. International customers (Recordeti, Cambrex, Sifavitor, Nycomed, Perkin Elmer
(Netherlands),Donghawa (Korea), ABC pharmaceuticals-Italy),BASF, AMSA, Chemicia
Fabrik (Germany), Euticals.
5. Domestic Customers: Hetero drugs, Zudus Cadilla, Cipla,Abott
Responsible for Divisional P&L.
BROAD PERFORMANCE AREAS
Quality Assurance
o Appraising the prevalent production systems/ processes, identifying loopholes if any and
undertaking result-oriented measures for alleviating them.
o Coordinating with customers for attending to their technical/ product related issues.
o Implementing steps for curtailing product/ process rejections and defects.
o Self audit and suppliers audit
o Gap analysis and action planning.
o GMP training to the staff.
o Validation
• Qualification of equipment
• Qualification of SCADA /PLC system
• Qualification of water system
• SOP writing
• BMR preparation
• Review of completed BMR’s
• Cleaning validation
KPI’s
 Production volumes and factory financial targets
ALOK
R&D Finance PurchaseFactory Marketing

5.  Statutory compliances
 Perfect supply
 Health and safety
 Best in Class cost
 Responsive supply
 IR
 Quality and improvement related projects
 Investigation of failures and salvaging the batches
 Giving the procedures for rework
 Trouble shooting in the process
 Product development
 Commissioning of the processes in the plant
Manufacturing/ Plant Operations
o Developing plans/ schedules for producing bulk drugs keeping in consideration procedural and
quality norms.
o Budgeting of the production for the year.
o Ascertaining resource requirements, making proper arrangement of the same to prevent
disruption of manufacturing operations at any stage.
o Establishing processes/ systems, focussing on optimisation parameters.
o Ensuring minimal machine breakdowns to curtailing machine downtime.
o Implementing good manufacturing practices for enhancing product yield and curtailing
expenses.
o Commissioning of the new processes and plant
o Implementing safe working practices by following laid down policies.
o Trouble shooting and rework procedure for salvaging the batches.
New Improvement Initiatives
o Commencing new product development functions as per the current market trends.
o Effectuating high-value added systems/ procedures to speed up production and exalt
output.
o Devising measures for exalting plant capacity utilization, product yield and quality.
o Commissioning of equipment and new products
o Failure investigation
o SOP preparation
Team Management
o Providing safety/ GMP training to subordinates to enhance awareness/ performance levels.
o Mentoring and motivating subordinates for exalting their competency skills.
Supply Chain Management
• Customer service
• Rough cut capacity planning
• Inventory control (WIP&RO + raw materials)
• Liasoning with customer and suppliers
• Production Planning
Health and safety
• Training
• Audits and spot checks
• Hazop studies
• Risk analysis
• Accident and dangerous occurrence analysis
• Chairing the safety meetings
• COSHH analysis and action planning

6. TRAINING PROGRAMMES ATTENDED
- Finance for non- finance persons - General Management Course
- Target setting - Plant and Operational Safety
- GMP Training - Action based safety
- TQM/ Lean Sigma
IT SKILLS: MS Office and MS Project
DATE OF BIRTH: 18th
August 1961.

7. TRAINING PROGRAMMES ATTENDED
- Finance for non- finance persons - General Management Course
- Target setting - Plant and Operational Safety
- GMP Training - Action based safety
- TQM/ Lean Sigma
IT SKILLS: MS Office and MS Project
DATE OF BIRTH: 18th
August 1961.