CURRICULUM VITAE
Address for Correspondence: SIVA PRASAD.K
Plot no-50,
Prasad_siva84@yahoo.com Suchitra,
Mobile No.: 919948848242 Hyderabad
CAREER OBJECTIVE:
To apply my knowledge & skills thus innovating, improving self for Producing
tremendous results towards the growth of esteemed organization.
WORK EXPERIENCE:
 Worked as a trainee in Aurobindo Pharma from June 2008 to April 2009.
 Worked in Sterile Oncology formulations as a Senior team member in Dr.Reddy’s
laboratories Microbiology department from May 2009-Oct 2013.
 Worked in Mylan laboratories-Oncology plant as a Executive in Quality control-
Microbiology department from Oct 2013-Apr 2014.
 At present I am working in Shantha Biotech Ltd. (Sanofi company) from Apr 2014 to
till date as a Senior officer.
 As a Microbiologist, I had an exposure in demonstrating the Microbiological
Methods, during the approval audits like WHO, UGANDA, UKRINE,
GSK, GCC and ANVISA.
SUMMARY SKILLS:
• Present working as QC-Microbiologist at sterile Biotech formulations facility for
Approved products.
• Well experienced in all the Microbiological activities and in fulfilling the
Documentation as per regulations.
• Demonstration of Microbiological methods during the audits.
• Conducting awareness programs to the personnel involved in the aseptic
process.
• In Process quality checking and monitoring during aseptic process.
• Good communicational and drafting skills.
JOB PREFERENCE:
• QA/QC Sterile Formulations.
WORK PROFILE:
I have worked in the following areas and developed a lot by experiencing to the Best of
my knowledge.
DOCUMENTATION ACTIVITIES includes
• Updating documents as per cGMP, EU, ICH and USP guidelines.
• Organizing and conducting the trainings on various guidelines.
• Document Compliance as per the regulations and quality systems.
• Controlled distribution and archiving of documents.
• In process quality checking during manufacturing.
• Preparation of quality data trends.
• Monitoring of validation activities.
 SOP’s and STP’s preparation
 Handling of Deviations
 Change controls and CAPA’s
 Investigations and Risk assessment studies
 Procurement and Maintenance of Laboratory consumables.
MICROBIOLOGICAL ACTIVITIES includes
• Monitoring of all the classified areas as per ISO, USP & EU.
• Clean room maintenance.
• Microbiological test methods.
• Culture procurement and maintenance.
• Disinfectant preparation.
• Microbial limit test.
• Bacterial endotoxin test.
• Sterility Test
• Autoclave operation.
• Calibration activities.
 Operation of VITEK-II system.
 Isolation of Environmental isolates.
 Media preparation and Growth promotion test
VALIDATION ACTIVITIES includes
• Validation of Steam & Dry heat Sterilizers.
• Purified, Pure steam and WFI water system validations.
 IOQ and PQ studies for Biological incubators
• Cleaning validation.
• Media fill study sterile formulations manufacturing facilities.
 Area qualification
 Media Hold time study.
• Microbiological method Suitability tests (BET, MLT).
• Sterility method Suitability tests.
• Microbiological spiking and reduction studies.
• Cleaning, Sanitization and Disinfection methodology (Disinfectant validation and
Hold time studies).
• Container closure integrity.
 Tunnel validation.
EDUCATION:
• M.Sc Microbiology -- NAGARJUNA.University -- 67%
• B.Sc Microbiology -- NAGARJUNA.University -- 71%
DECLARATION:
I feel that I would bring a resourcefulness of years of experience in a wide range of disciplines
having good work ethic and the capability, and I hereby declare that the above details are true to
best of my knowledge and I am personally responsible for the authenticity of the same.
(K.SIVA PRASAD)

RESUME

  • 1.
    CURRICULUM VITAE Address forCorrespondence: SIVA PRASAD.K Plot no-50, Prasad_siva84@yahoo.com Suchitra, Mobile No.: 919948848242 Hyderabad CAREER OBJECTIVE: To apply my knowledge & skills thus innovating, improving self for Producing tremendous results towards the growth of esteemed organization. WORK EXPERIENCE:  Worked as a trainee in Aurobindo Pharma from June 2008 to April 2009.  Worked in Sterile Oncology formulations as a Senior team member in Dr.Reddy’s laboratories Microbiology department from May 2009-Oct 2013.  Worked in Mylan laboratories-Oncology plant as a Executive in Quality control- Microbiology department from Oct 2013-Apr 2014.  At present I am working in Shantha Biotech Ltd. (Sanofi company) from Apr 2014 to till date as a Senior officer.  As a Microbiologist, I had an exposure in demonstrating the Microbiological Methods, during the approval audits like WHO, UGANDA, UKRINE, GSK, GCC and ANVISA. SUMMARY SKILLS: • Present working as QC-Microbiologist at sterile Biotech formulations facility for Approved products. • Well experienced in all the Microbiological activities and in fulfilling the Documentation as per regulations. • Demonstration of Microbiological methods during the audits. • Conducting awareness programs to the personnel involved in the aseptic process. • In Process quality checking and monitoring during aseptic process.
  • 2.
    • Good communicationaland drafting skills. JOB PREFERENCE: • QA/QC Sterile Formulations. WORK PROFILE: I have worked in the following areas and developed a lot by experiencing to the Best of my knowledge. DOCUMENTATION ACTIVITIES includes • Updating documents as per cGMP, EU, ICH and USP guidelines. • Organizing and conducting the trainings on various guidelines. • Document Compliance as per the regulations and quality systems. • Controlled distribution and archiving of documents. • In process quality checking during manufacturing. • Preparation of quality data trends. • Monitoring of validation activities.  SOP’s and STP’s preparation  Handling of Deviations  Change controls and CAPA’s  Investigations and Risk assessment studies  Procurement and Maintenance of Laboratory consumables. MICROBIOLOGICAL ACTIVITIES includes • Monitoring of all the classified areas as per ISO, USP & EU. • Clean room maintenance. • Microbiological test methods. • Culture procurement and maintenance. • Disinfectant preparation. • Microbial limit test. • Bacterial endotoxin test.
  • 3.
    • Sterility Test •Autoclave operation. • Calibration activities.  Operation of VITEK-II system.  Isolation of Environmental isolates.  Media preparation and Growth promotion test VALIDATION ACTIVITIES includes • Validation of Steam & Dry heat Sterilizers. • Purified, Pure steam and WFI water system validations.  IOQ and PQ studies for Biological incubators • Cleaning validation. • Media fill study sterile formulations manufacturing facilities.  Area qualification  Media Hold time study. • Microbiological method Suitability tests (BET, MLT). • Sterility method Suitability tests. • Microbiological spiking and reduction studies. • Cleaning, Sanitization and Disinfection methodology (Disinfectant validation and Hold time studies). • Container closure integrity.  Tunnel validation. EDUCATION: • M.Sc Microbiology -- NAGARJUNA.University -- 67% • B.Sc Microbiology -- NAGARJUNA.University -- 71% DECLARATION: I feel that I would bring a resourcefulness of years of experience in a wide range of disciplines having good work ethic and the capability, and I hereby declare that the above details are true to best of my knowledge and I am personally responsible for the authenticity of the same.
  • 4.