VEERANJANEYA KUMAR M

M.Pharmacy, CSV consultant, 7+ year’s exp.

Mobile no.: +916301201012
Mail Id.: kumarm507@gmail.com

Objective:
To perform a responsible and challenging job in a reputed organization, where my acquired experience and
skills get utilized to my full potential and find a quality environment where my knowledge and skills can be
shared and enriched to improve and grow and set and achieve long-term goals.
Summary:
I have around 7+ years of experience in Pharmaceutical and Healthcare Industry with Software
Development Life Cycle, 21 CFR Part-11 and Annexure-11 Validation, Auditing, Change Control,
CAPA, Deviation Procedures and implementation of business applications. Have handful of experience
in, cGxP environment as per international guidelines like ICH, GAMP-5, EUAnnexure-11 and FDA using
state of competent professional in computerized system validation (Application, Instrument & Equipment
system validation).

Job Description at Syngene international PVT Ltd, (Computer system validation):

 Experience in generating and reviewing Computer Systems Validations CSV Deliverables according to
21 CFR Part 11 and FDA regulations for the Pharmaceutical industries.
 Experience in reviewing User Requirement Specifications URS, Functional Requirements Specification
FRS and Requirement Traceability Matrix (RTM).
 Monitoring functional and design specifications (FS and DS), testing protocols (IQ/OQ/PQ), User
acceptance testing, traceability matrices, validation reports and change control documentation to support
all validation activities as per the validation master plan.
 Experience in preparation, review and approval of Validation Protocols IQ/OQ/PQ documentation, VP,
SOPs, Protocol Deviation, and Risk Assessment.
 Expertise in reviewing the IQ/OQ/PQ summary reports.
 Expert in Handling of Business systems and Laboratory Applications application.
 Review and approval of Change controls, CAPA and Deviation.
 Having exposure to Internal Audits, Customer Audits and Regulatory Audits which includes the
preparation for audit, providing timely effective response for the same.
 Actively Participated in USFDA, TGA, and MHRA Audits
Work experience:

Work experience: 7+ years.

 CSV consultant in Syngene international PVT Ltd, Through Talluri Pharma pvt ltd, Hyderabad (JAN-
2022 to till date).
 Sr. Executive in Prayosha health care pvt Ltd.(15-07-2019 to 18-12-2021)
 Sr. Reviewer in Quality Assurance at GSR Pharma (IPCA) Ratlam, Madyapradesh (Sep-2018
To May-2019).
 Sr. Executive in Stability Dept. Apotex Research Pvt Limited, Bangalore, Karnataka from (Dec-2016 to
Jul- 2018).
 Sr. Executive in Stability Dept. Syngene international pvt ltd, Bangalore, Karnataka from (Oct-2015 to
Nov- 2016).
 Executive in Stability Dept. Actavis pharmaceutical pvt ltd., (Jul 2013 to Oct 2015).

Professional Skills:
 Expertise in Auditing and Compliance prospects (QA).
 Expertise and acquainted in CSV deliverables including Risk assessment and reviewing protocols in
line with 21 CFR part 11 compliance, GAMP 5 and related to all computerized systems
Personal Strength:
 Work planning, time management, team management, communication skills and result oriented with the
ability to work under the pressure.
 Take challenges, work hard and smart to achieve the set goals.
 Working as per GLP principles.
Academic profile:
Post-Graduation - M. Pharmacy (Pharmaceutical analysis) from Swamy Vivekanandha college of pharmacy,
Erode, Tamilnadu (Dr. M.G.R University, Chennai, TN) (2011-2013).

Graduation - Pharmacy from Kamalakshi Pandurangan College of pharmacy Tiruvannamalai,

(Dr. M.G.R University, Chennai, TN).
Personal details:
VEERANJANEYA KUMAR MEDATHATI
# 543/3, Back side of SV hotel and
restaurant, Omax circle, Jigani road,
Bangalore, KA, 560099.
DECLARATION:

I do here by declare that the particulars of information and facts stated here in above are true, correct and
complete to the best of my knowledge and belief.

Place: Bangalore
Date: VEERANJANEYA KUMAR M