Siva Prasad is seeking a position in QA/QC for sterile formulations. He has over 10 years of experience in microbiology working for several pharmaceutical companies. His experience includes conducting microbiological testing, cleaning validations, document control, and training personnel on cGMP guidelines. He is proficient in microbiological methods and validation activities for sterile drug manufacturing facilities.
Good laboratory practices in a pharmaceutical lab 1
RESUME
1. 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.
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
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.