Turkey: Soil Fertilizer and Water Resources, Central Research Institute
RESUME
1. CURRICULUM VITAE
Address for Correspondence: SIVA PRASAD.K
PLOT NO-155,
Road No-10,
Vediri town ship,
Prasad_siva84@yahoo.com Swarnapuri colony-72.
Phone: 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 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
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.
3. • Calibration activities.
Operation of VITEK-II system.
Isolation of Environmental isolates.
VALIDATION ACTIVITIES includes
• Validation of Steam & Dry heat Sterilizers.
• Purified and WFI water analysis.
• Cleaning validation.
• Media fill study sterile formulations manufacturing facilities.
• Microbiological method validations (BET,MLT).
• Sterility method validations.
• Microbiological spiking and reduction studies.
• Cleaning, Sanitization and Disinfection methodology.
• Seal 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)