1. `
M. SUKUMAR
msk3175@yahoo.com
• +91-9865479052, 7373734806
Scaling new heights of success with hard work & dedication and leaving a mark of excellence on
each step; aiming for senior level assignments in production
M.Sukumar. M.Sc Chemistry
Heading Production General API
Good Exposure in Documentation, Audit Compliances.
Leadership Quality
Continuous success in USFDA &WHO Audits
Good in Planning and Execution with Budgeted cost
Best Performer for the year -2013 & 2014 for the Group Companies of Acebright-Previous
Employer
ORGANISATIONAL EXPERIENCE:
Name of the
Company
Location Period of Working Position Held
Strides Shasum
Pharmaceutical Pvt
Ltd.
Cuddalore-Tamil
Nadu
Mar-2016 to Till Date AGM-Production
Acebright
(India)Pharma Pvt Ltd
Bangalore Sep-2009 to Feb-2016 AGM-Production.
Apotex Pharmachem
India Pvt Ltd
Bangalore May-2006 to Sep-2009 Group Leader.
Jubilant Organosys Mysore Feb-2005 to April-2006 Officer
Dr.Reddys Lab Hydreabad July-2003 to Jan-2005 Executive
Orchid Chemicals Chennai Sep-2000 to July-2003 Junior Executive
2. `
&Pharmaceuticals
Educational Qualification:
SSLC 1990 to 1991 Pachaiyappas Hr. Sec
School
Tamil Nadu State Board, India
HSC 1991 to 1993 Pachaiyappas Hr. Sec
School
Tamil Nadu State Board, India
B.Sc
(Chemistry)
1993 to 1996 Arignar Anna Govt. Arts
and Science College
Madras University, India
M.Sc
(Chemistry)
1996 to 1998 D.G Vaishnava College Madras University, India
JOB PROFILE:
Current Employer:
Strides Shasun Pharmaceutical Pvt Ltd, Cuddalore.
• Heading the API Manufacturing with the Capacity of 60 MT per month and 720 MT per
annum, which consists of 3 Production Block with USFDA,WHO,TGA Approved facility.
• Out of 3 production Block, 2 Blocks are dedicated facility for the Product and One Facility
with Multipurpose Block.
• Heading Technical service for the coordination of Process scale up and Optimization.
• Responsible for Cost control with Budgeted cost.
• Astute leader with ability to motivate sub ordinate in optimizing performance level, leading a
group of about 300 on roll employees.
• Responsible for New product mapping in the multipurpose plant facility and process
validation with CFT.
• Responsible to Handle the Market complaints
• Responsible to Handle Regulatory and Customer Audits
Previous Employer:
3. `
Acebright India Pharmachem Pvt Ltd, Bangalore
• Headed Manufacturing for General ARV Production Block and Oncology Production Block
with the Capacity of 120 MT of General ARV in Multipurpose production Block and 20 MT
per annum of Oncology Production Block
• Heading small scale with High Cost capacity for 2 kilo labs.
• Key Responsible for Production, Planning for the 4 nos of Multi purpose plants
• Responsible for On time delivery to the Customer keeping the Lead time with No negotiation
with Safety and by following the GMP Compliances.
• Responsible for the company’s operation of the both the ARV and Oncology operation and
low volume and High cost product in kilo labs
• Successfully launched the validation and commercial products in Oncology API & General
API’s.
• Responsible for Process validation, Cleaning validation and Qualification of Process
Equipments.
• Demonstrated ability to lead the resolution higher impact more complex issues opportunity
with minimal guidance and direction
• Excellent productive communication skills
• Demonstrated capability in the application of sound engineering and scientific principles,
project management skills, structured analytical problem-solving techniques and statistical
analysis
• Proven leadership capability to work cross-departmentally with various functional leaders or
senior management at and above site; demonstrated leader of multi-disciplinary teams
• Responsible for Target plan, control of inventory to meet the production target as per the
schedule within the accepted standards of performance with respect to material consumption
norms, time of Production planning and Inventory control according to the market demand.
• Installation of system based on the Application of Products ,OEL limits of the products,
potency of the products ,dedicated gowning and de gowning procedure along with training of
the people has been the key areas handled
• Running the manufacturing plant with 100% utilization of capacity for productivity and
minimum breakdowns and to meet the c GMP requirement.
• Co-ordinate with process development team for cost reduction.
4. `
• Having very good Exposure in SAP &Involved in Planning and validation of ERP
Quality Management Excellence:
• Handled all the regulatory Audits of USFDA, WHO & MHRA individually and having very
good exposure for inline with the Regulatory norms for Production
• Responsible for Vendor Qualification Audit for Key starting materials
• In depth knowledge of Quality management systems of the principles of Quality by design
• Reviewing of Technology transfer document, Master formula record and Batch
manufacturing record.
• Responsible for all production deviation are reported, evaluated and critical deviations are
investigated.
• Ensuring the production personnel are appropriately trained to Safety, Hygiene and GMP
periodically.
• To handle and investigate all deviations/OOS/complaint/OOT observed as per standard
procedure.
• To investigate, record and report to Quality Assurance any problem which may adversely
affect the quality of the material
• Responsible to lead the Regulatory and customer Audits and respond according to the
compliance.
Project Excellence:
• I joined the organization in Acebright India Pharma Pvt Ltd before the commencement of the
project of Oncology and I was responsible for coordinating with projects for installing the
state of the art facility to manufacture oncology products and then General API Block
revamped with new facility for that coordinated with Projects.
• Involved in the project from the stage of inception, worked in co –ordination with projects
for successfully installing the state of the Art manufacturing facility, which is based on High
containment principles of OSHA and USFDA Guidelines.
• Involved for finalization of Layout, Equipment layouts to have unidirectional flow, selection
of process Equipments as per the process, Ergo trials of isolators based on the process, FAT’s
of all the process Equipments and Isolators.
• System to effectively handle the toxic emissions and processes to deactivate them were
formulated and installed in place
5. `
• Facilities in which these products are handled include General ventilation of 5 micron filters
to dedicated AHU’s of CLASS 100,000 and physical barrier negative pressure isolators to
handle oncology products of containment level 4 (OEL is between 0.1µg to 10 µg /CUM per
8 hrs)
Major Achievements:
• Being an Production Head involved in the regulatory audits by TGA ,USFDA and customer
audits as a Lead Auditee.
• Successful completion of USFDA for the products Efavirenz and Tenofovir disoproxil
Fumarate for the year july-2015
• Successful completion of WHO Geneva audit for the Product Efavirenz.USP, Tenofovir
Disoproxil Fumarate and Lopinavir for the year 2013,2014 &2015 respectively.
• Great Appreciation received from USFDA auditor.
• Zero observation in Production department and Very Great appreciation received from WHO
& FDA Auditors.
• Best Performer award for Operational Excellence for the year 2015 and 2016
Personal Profile
Gender : Male
Marital Status : Married
Date of Birth : 31 .07.1975
Languages Known : English, Tamil, Telugu, Kannada &Hindi
Passport No.& Date of Expiry : L1027395 05.05.2023
Permanent Address : No: 60,C Aladi Pillaiyar koil street ,
Kanchipuram,
Tamil Nadu-631501
India .
