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COVERING LETTER
From:
S. Sivakumar,
S/o M. Swaminathan,
257/2 Subramania nagar,
Hebbal 3rd stage,
Mysore- 570016.
To
The HR department
Sub: Application for suitable post.
Respected Sir/Madam,
I am holding Masterate in Microbiology in Bharathidasan University,
Tamilnadu and scored with distinction. I am currently working as QC Microbiology Team leader
in Reckitt Benckiser LTD, Mysore, India, from April 2015 to till date. I believe that my strong
education will make a very competitive candidate for your organization. Herewith I have enclosed
my curriculum vitae for your kind perusal.
Thank you for your time and consideration. I am hoping your positive response.
Place: Mysore yours sincerely
Date: 21 DEC 2015 Sivakumar S
CURRICULAM VITAE
S. Sivakumar
s/o M. Swaminathan,
257/2 Subramania nagar,
Hebbal 3rd stage, Mobile: 08880583411
Mysore-570016. microsiva@yahoo.co.in
CAREER OBJECTIVE
Looking for the position where I can learn, develop and utilize my skills and knowledge,
grow to the higher level and build a strong career within the organization.
ORGANISATIONAL EXPERIENCE
 Working as Officer QC Microbiology Team leader in Reckitt Benckiser LTD from April
2015 to till date. This organization is engaged in manufacturing and exporting of various
formulations like tablets and antiseptic liquids and has the approval of MHRA.
 Worked as Senior Executive in QC Microbiologist in Agila specialities ltd A Mylan
Company from June 2014 to March 2015. This organization is engaged in manufacturing
and exporting of various formulations and has the approvals of USFDA, MHRA, ANVISA,
AFSAP, TGA and MCC.
 Worked as Senior Executive QC Microbiologist in Biocon limited, Bangalore, India, from
August 2010 to June 2014. This organization is engaged in manufacturing and exporting of
various formulations. Biocon have the approvals of USFDA, WHO, MHRA, ANVISA,
AFSAP, TGA and KFDA.
 Worked as QC Junior Executive Microbiologist in Orchid chemicals and
pharmaceuticals Ltd., Chennai India, from July 2009 to August 2010. This organization is
engaged in sterile API manufacturing and exporting of various formulations like tablets and
liquid injectables including lyophilized drug products, beta-lactum cephalosporin, Penicillin,
Carbophenems and Phenems. Orchid chemicals and pharmaceuticals Ltd. have the approvals
of USFDA, MHRA, TGA and WHO.
CURRENT JOB PROFILE
 Leading the Microbiology team.
 Quality management system and compliance of microbiology department.
 Handling Deviation, Change control, OOT and OOS in microbiology department through
Track wise programming.
 Review, approval and release of microbiology analytical data of raw materials and finished
products and trend analysis.
 Equipment qualification and other miscellaneous validation studies protocol preparation and
execution.
 Indent making, Batch release and inventory maintenance through JDE program.
VALIDATION EXPOSURE
 MLT method validation for non-sterile products for Microbial enumeration test and test for
specified microorganisms with neutralizers.
 BET method validation for non-sterile products by gel clot method.
 Equipment qualification for Laboratory freezer, Laboratory refrigerator, Refrigerated
incubator, Autoclave, Hot air oven and Heating block.
 Disinfectant validation
MISCELLANEOUS VALIDATION ACTIVITIES
 Evaluation of swab recovery studies.
 Evaluation of growth promoting properties for the media plates after passive air sampling
and active air sampling.
 Evaluation of vendor contact plate.
 Evaluation of hold time study for the purified water stored in HDPE container.
 Dirty hold time study for the reactors and shifters used in manufacturing areas.
 Cleaning hold time study for the reactors and shifters used in manufacturing areas.
DOCUMENTATION ACTIVITIES
 Preparation of protocol, execution and final summary of routine revalidation
 Preparation of Standard operating procedures, equipment operating procedure, specification
and method of analysis.
 Preparation of miscellaneous validation protocols for audit compliances.
 Preparation of area qualification protocol and environmental monitoring plans.
 To lay down Quality Assurance system to ensure cGMP/ cGLP compliance at Plant/Quality
control department as per quality standards.
MICROBIOLOGY LAB ACTIVITIES
 Media stock maintenance of dehydrated media and ready to use media and their growth
promotion test.
 Handling of cultures and identification by Vitek 2 compact system.
 Environmental monitoring by passive air sampling, active air sampling, surface monitoring,
personnel monitoring and extensive sampling.
 Bio ball receipt, storage and QC test approval and its identification.
 MLT of water, raw materials, packing materials and related validation.
 Calibration/Validation for the instruments handled in microbiology laboratory.
 Sterility Analysis.
 Biological indicators population assay.
 Responsible for imparting training to subordinates as per SOP and on current GMP practices.
 Responsible for reporting to quality control manager on regular basis on compliance.
 To submit compliance of any of the non-compliance served by audit.
 Coordination, testing and reporting for all validation activity of production.
 To approve or hold or reject the finished product, in process bulk, final bulk, inactive raw
material or active raw material.
 To ensure cGMP in manufacturing facility.
AUDIT EXPOSURE
 I faced MHRA audit in Reckitt Benckiser on May2015 and successfully passed with zero
observation in microbiology department.
 I participated and faced as effective team member with regulatory requirement of USFDA,
EuGMP, AFSSAP, KFDA, MHRA, ANVISA and MCC.
INTERNAL TRAINING AND CERTIFICATIONS
 Water for pharmaceutical Faculty/A to Z of water system: Teri.C Soli from US.
 Participated the seminar on bacterial endotoxin test –Faculty: Mr. Blue Menthol from US.
 LIMS implementation for EM and utility by Susan from Novatek ltd.
 Applying Kaizen in microbiology labs.
PERSONAL SKILLS AND COMPETENCIES
 A balancing team player and quick learner.
 Time managing person, Out of box thinker and Assertive communicator.
 Self–motivated achiever with an established reputation for reliability, hard work,
commitment, and flexibility.
 Optimistic, dynamic, can easily adapt to environment and changing situations.
ACADEMIC CHRONICLE
Qualification Board/University Institution
Year of
Passing
Percentage
of Marks
M.Sc
Microbiology
BharathidasanUniver
sity
SrimadAndavan
college
2009 80 %
P.G.D.H.T BharathidasanUniver
sity
SrimadAndavan
college
2008 82 %
P.G.D.C.A - CCI computer
Education
2009 71 %
DMLT All India Institute of
Medical Technology
Vigneshwara
Institute Of
Paramedical
sciences
2008 70 %
B.Sc
Microbiology
PeriyarUniversity Vysya college 2007 70 %
HSC State Board Tagore higher
secondary school
2004 84 %
SSLC Matriculation Balamandir
Matriculation
school
2002 65 %
PERSONAL PROFILE
 Date of Birth: 25 September 1987
 Marital Status: Married
 Languages known: English, Tamil and Kannada.
 Permanent address: No 3/110 C, Veerakaran Kovil Street, Sarkar kollapati village, Salem
District. 636030
Declaration:
I hereby declare that all the above information is true to the best of my knowledge.
Place: Mysore Yours sincerely
Date: 21 DEC 2015 Sivakumar S

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CV

  • 1. COVERING LETTER From: S. Sivakumar, S/o M. Swaminathan, 257/2 Subramania nagar, Hebbal 3rd stage, Mysore- 570016. To The HR department Sub: Application for suitable post. Respected Sir/Madam, I am holding Masterate in Microbiology in Bharathidasan University, Tamilnadu and scored with distinction. I am currently working as QC Microbiology Team leader in Reckitt Benckiser LTD, Mysore, India, from April 2015 to till date. I believe that my strong education will make a very competitive candidate for your organization. Herewith I have enclosed my curriculum vitae for your kind perusal. Thank you for your time and consideration. I am hoping your positive response. Place: Mysore yours sincerely Date: 21 DEC 2015 Sivakumar S
  • 2. CURRICULAM VITAE S. Sivakumar s/o M. Swaminathan, 257/2 Subramania nagar, Hebbal 3rd stage, Mobile: 08880583411 Mysore-570016. microsiva@yahoo.co.in CAREER OBJECTIVE Looking for the position where I can learn, develop and utilize my skills and knowledge, grow to the higher level and build a strong career within the organization. ORGANISATIONAL EXPERIENCE  Working as Officer QC Microbiology Team leader in Reckitt Benckiser LTD from April 2015 to till date. This organization is engaged in manufacturing and exporting of various formulations like tablets and antiseptic liquids and has the approval of MHRA.  Worked as Senior Executive in QC Microbiologist in Agila specialities ltd A Mylan Company from June 2014 to March 2015. This organization is engaged in manufacturing and exporting of various formulations and has the approvals of USFDA, MHRA, ANVISA, AFSAP, TGA and MCC.  Worked as Senior Executive QC Microbiologist in Biocon limited, Bangalore, India, from August 2010 to June 2014. This organization is engaged in manufacturing and exporting of various formulations. Biocon have the approvals of USFDA, WHO, MHRA, ANVISA, AFSAP, TGA and KFDA.  Worked as QC Junior Executive Microbiologist in Orchid chemicals and pharmaceuticals Ltd., Chennai India, from July 2009 to August 2010. This organization is engaged in sterile API manufacturing and exporting of various formulations like tablets and liquid injectables including lyophilized drug products, beta-lactum cephalosporin, Penicillin, Carbophenems and Phenems. Orchid chemicals and pharmaceuticals Ltd. have the approvals of USFDA, MHRA, TGA and WHO.
  • 3. CURRENT JOB PROFILE  Leading the Microbiology team.  Quality management system and compliance of microbiology department.  Handling Deviation, Change control, OOT and OOS in microbiology department through Track wise programming.  Review, approval and release of microbiology analytical data of raw materials and finished products and trend analysis.  Equipment qualification and other miscellaneous validation studies protocol preparation and execution.  Indent making, Batch release and inventory maintenance through JDE program. VALIDATION EXPOSURE  MLT method validation for non-sterile products for Microbial enumeration test and test for specified microorganisms with neutralizers.  BET method validation for non-sterile products by gel clot method.  Equipment qualification for Laboratory freezer, Laboratory refrigerator, Refrigerated incubator, Autoclave, Hot air oven and Heating block.  Disinfectant validation MISCELLANEOUS VALIDATION ACTIVITIES  Evaluation of swab recovery studies.  Evaluation of growth promoting properties for the media plates after passive air sampling and active air sampling.  Evaluation of vendor contact plate.  Evaluation of hold time study for the purified water stored in HDPE container.  Dirty hold time study for the reactors and shifters used in manufacturing areas.  Cleaning hold time study for the reactors and shifters used in manufacturing areas. DOCUMENTATION ACTIVITIES  Preparation of protocol, execution and final summary of routine revalidation  Preparation of Standard operating procedures, equipment operating procedure, specification and method of analysis.  Preparation of miscellaneous validation protocols for audit compliances.
  • 4.  Preparation of area qualification protocol and environmental monitoring plans.  To lay down Quality Assurance system to ensure cGMP/ cGLP compliance at Plant/Quality control department as per quality standards. MICROBIOLOGY LAB ACTIVITIES  Media stock maintenance of dehydrated media and ready to use media and their growth promotion test.  Handling of cultures and identification by Vitek 2 compact system.  Environmental monitoring by passive air sampling, active air sampling, surface monitoring, personnel monitoring and extensive sampling.  Bio ball receipt, storage and QC test approval and its identification.  MLT of water, raw materials, packing materials and related validation.  Calibration/Validation for the instruments handled in microbiology laboratory.  Sterility Analysis.  Biological indicators population assay.  Responsible for imparting training to subordinates as per SOP and on current GMP practices.  Responsible for reporting to quality control manager on regular basis on compliance.  To submit compliance of any of the non-compliance served by audit.  Coordination, testing and reporting for all validation activity of production.  To approve or hold or reject the finished product, in process bulk, final bulk, inactive raw material or active raw material.  To ensure cGMP in manufacturing facility. AUDIT EXPOSURE  I faced MHRA audit in Reckitt Benckiser on May2015 and successfully passed with zero observation in microbiology department.  I participated and faced as effective team member with regulatory requirement of USFDA, EuGMP, AFSSAP, KFDA, MHRA, ANVISA and MCC. INTERNAL TRAINING AND CERTIFICATIONS  Water for pharmaceutical Faculty/A to Z of water system: Teri.C Soli from US.  Participated the seminar on bacterial endotoxin test –Faculty: Mr. Blue Menthol from US.  LIMS implementation for EM and utility by Susan from Novatek ltd.  Applying Kaizen in microbiology labs.
  • 5. PERSONAL SKILLS AND COMPETENCIES  A balancing team player and quick learner.  Time managing person, Out of box thinker and Assertive communicator.  Self–motivated achiever with an established reputation for reliability, hard work, commitment, and flexibility.  Optimistic, dynamic, can easily adapt to environment and changing situations. ACADEMIC CHRONICLE Qualification Board/University Institution Year of Passing Percentage of Marks M.Sc Microbiology BharathidasanUniver sity SrimadAndavan college 2009 80 % P.G.D.H.T BharathidasanUniver sity SrimadAndavan college 2008 82 % P.G.D.C.A - CCI computer Education 2009 71 % DMLT All India Institute of Medical Technology Vigneshwara Institute Of Paramedical sciences 2008 70 % B.Sc Microbiology PeriyarUniversity Vysya college 2007 70 % HSC State Board Tagore higher secondary school 2004 84 % SSLC Matriculation Balamandir Matriculation school 2002 65 %
  • 6. PERSONAL PROFILE  Date of Birth: 25 September 1987  Marital Status: Married  Languages known: English, Tamil and Kannada.  Permanent address: No 3/110 C, Veerakaran Kovil Street, Sarkar kollapati village, Salem District. 636030 Declaration: I hereby declare that all the above information is true to the best of my knowledge. Place: Mysore Yours sincerely Date: 21 DEC 2015 Sivakumar S