Kanuri Prasad is seeking a career in quality assurance and regulatory affairs in the pharmaceutical manufacturing industry. He has over 4 years of experience in quality assurance at Vasudha Pharma Chem Limited, where he currently holds the role of Executive in the Corporate Quality Assurance department. His responsibilities include vendor qualification, change control reviews, complaint investigations, and preparation of regulatory documents like Drug Master Files. He holds a B.Pharmacy degree and has experience in process validation, cleaning validation, and internal auditing.
1. CURRICULAM VITAE
Kanuri. Prasad
23-11-13, Simhagiri colony, E-mail: prasad16791@gmail.com
New Gajuwaka, Mobile: 9989357501
Visakhapatnam-530026.
CAREER OBJECTIVE
Seeking challenging career in Quality Assurance & Regulatory Affairs in manufacture of products
meeting highest quality standards thereby contributing to the enhancement of brand equity of the
company for which I am working. Setting of superior personal goals in tune with corporate goals &
striving constantly to reach the same. Promoting & practicing excellent work culture & encouraging
team building so as to give productivity that can match the top in the industry.
EXECUTIVE SUMMARY
A competent professional with 4 years of Quality Assurance experience in Pharmaceuticals
Manufacturing.
Presently associated with “Vasudha Pharma Chem Limited” as an Executive in Corporate
Quality Assurance (CQA) Department.
Handling of Deviations, Change Controls, Incident reporting and investigation, market
complaints investigation.
Qualification of vendors and contract manufacturing units and ensuring the effective
documentation from the vendors.
Hands on experience in Cleaning validation, Equipment qualification, vendor qualification
and audits.
Monitoring of Shop floor activities for cGMP compliance.
Hands on experience in preparation of DMFs for EU and US, and responding to deficiency
letters.
An excellent communicator with exceptional interpersonal skills and technical skills.
Undergone a 6 months training on Basic process engineering techniques.
PROFESSINAL EXPERIENCE
Executive – CQA, VASUDHA PHARMA CHEM LIMITED (Since October 2015)
Reporting to Head-Corporate Quality
As an Executive – CQA, responsible for core level monitoring of quality compliance and supporting
of site QAs in Quality related issues. My Job responsibilities are delegated as
Monitoring of vendor qualification activities in all sites and updating the Approved vendor list
whenever required.
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2. Prasad Kanuri, 9989357501
Planning for the Audits of vendors, Contract laboratories and service provider’s and
supporting site QAs during vendor/service provider qualification as co-auditor.
Review of vendor documents and evaluation of the vendor documents as per the standard
requirements.
Preparation of Core Standard operating procedures, to harmonize the different site level
procedures with proper gap assessment.
Monitoring of CAPA records and follows up for regular updating of CAPA tracking and
status records from all individual sites.
Review of change controls and evaluating the impact assessment for major changes, and
providing necessary approvals for change controls.
Review of complaints and coordinating with site QAs during preparation of complaint
investigation reports.
Preparation of customer & regulatory audit compliance reports and providing appropriate
CAPAs. Review of due CAPAs with timely verification.
Review and approval of analytical method validations and method transfer protocols.
Preparation and review of monthly reports by gathering information from the site QAs & QCs
to present during the Management review meetings.
Preparation of Quality agreements with the suppliers and external service providers and
coordinating the same with the site QAs.
Review of Drug master files and regulatory deficiencies in support to RA department.
Participating in Technology transfer and Site transfer meetings. Review of respective tech
packs for necessary requirements.
VASUDHA PHARMA CHEM LIMITED (August 2012 to September 2015)
Reporting to Manager-QA.
As a Chemist – QA, responsible for below listed activities.
Issue, retrieval and archiving of documents.
Supporting to QMS related activities like Change controls, Deviations, Complaints, Vendor
qualification etc…
Preparation of Drug master file Open and restricted parts and submitting to the customers
based on requirements until a common RA functions were initiated.
Later on responsible as a coordinator for RA department in sharing the respective documents
related to filing of Drug master files.
Preparation of change notifications for the Major changes.
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3. Prasad Kanuri, 9989357501
Issue and logging of Out of specification forms and allotting OOS number for the same.
Actively participated in phase-II OOS investigations in identifying the route cause.
Coordinating with packing and marketing department for timely dispatch activities, and
review of Batch records, Analytical records and packing records.
Preparation and review of Process validation and Cleaning validation protocols and reports.
Associated with R&D department (Technology transfer team) for process optimization and
successful technology transfer activities.
Preparation of GMP and On Job training planner, Internal Audit planner and coordinating
with internal departments for effective internal auditing processing.
Filling of Vendor evaluation forms and communicating with the customers for all technical
support.
Review and compilation of Annual Product Reviews (APR).
Preparation of drug files for getting approvals from Local drug department for test licenses,
drug licenses, GMP inspections, CDSCO approvals etc…
Worked as an IPQA team member for process monitoring and identification of process non-
conformities.
CAREER ACHIEVEMENTS
Actively participated in designing a new project for manufacturing of finished formulations
from the inception of project design to construction, installation of equipments & AHUs,
Qualification and implementation of quality systems.
Established development quality assurance at newly initiated R&D centre and supported AD
& R&D in preparation of SOPs, qualification of instruments, and applying for test license
activities.
ACADEMIC CREDENTIALS
B.Pharmacy from Yalamarty College of Pharmacy affiliated to Andhra University, with an
SGPA of 7 out of 10. Passed out in 2012.
Intermediate from Sri Chaitanya Junior College, with a percentage of 82. Passed out in 2008.
SSC from Siddardha Public School, with a percentage of 85. Passed out in 2006
ACADEMIC PROJECT
Title: Evaluation and Comparison of Anti diabetic activity of hydro alcoholic extracts of fresh and
dry leaves of Psidium guajava in type II diabetes mellitus.
PRESENTATIONS GIVEN
Actively participated in various national level seminars and below are the presentations presented
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4. Prasad Kanuri, 9989357501
“Instrumentation used for impurity profiling in pharmaceutical dosage forms” in Maharaja
college of Pharmacy and won first prize for the presentation.
”Neuromuscular blockers” in Maharaja college of pharmacy.
“Recent advances in pharmaceutical nanotechnology” in ANITS college of biotechnology.
“Recent advances in pharmaceutical nanotechnology” in Vignan institute of pharmaceutical
sciences.
TECHNICAL PROFILE
• Proficient in MS-Office and computer handling.
• Undergone 6 month training on “Basic process engineering techniques” by the
esteemed professors of Gayatri Vidya Parished. And a project submitted with a title of
“Analytical techniques used for the Quantitative analysis of compounds”.
ARTICLES PUBLISHED
An articles was published in International journal of Pharmaceutical science and research with
a title of “Science and risk based approach to the process validation – Link from Quality by
design to process validation”. This article can be downloaded with below link.
http://ijpsr.com/wp-content/uploads/2016/03/4-Vol.-7-Issue-3-March-2016-IJPSR-RE-17831.pdf
STRENGTHS
Hard working
Time management skills
Problem solving skills
Presentation skills
Communication skills
IT & Technical skills
Good knowledge on regulatory requirements
PERSONAL INFORMATION
Name : Kanuri Prasad
Date of Birth : 16-07-1991
Father name : Thatha babu
Marital status : Married
Nationality : Indian
Address : 23-11-13,Simhagiri colony,
New Gajuwaka, Visakhapatnam-530026.
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