1. COVER LETTER
Respected Sir/Madam,
I am K Madhu Krishna Raju Masters from Andhra University under the stream
of Electronics and Systems design in 2012. I am looking forward to work in an esteemed organization
where I can utilize my skill for the development of the firm and to update my knowledge according to the
latest trends.
Now I am working in Gland Pharma Limited, Hyderabad. With 2+ year of professional experience as a
Computer system validation (CSV) engineer. As I am interested to gain experience under Industrial
sector/IT Sector, provide me an opportunity to work in your esteemed organization. I attached my CV
with this mail, hope with your response I can fulfil my desire to work in an esteemed organization.

2. CURRICULUM VITAE
Madhu Krishna Raju, Email: madhuvarma45@gmail.com
Hyderabad. Contact: +91-9441090235.
Seeking career enrichment opportunity in the domain of Computer System Validation (CSV) & Compliance
in a Reputed Company.
PROFESSIONAL EXPERIENCE
A dynamic professional with 2+ year of experience in Computer System Validation (CSV) & Compliance
in Gland Pharma Limited, Hyderabad.
ROLES AND RESPONSIBILITIES.
 Facilitate and implementation of a quality Systems which complies and in accordance with FDA 21
CFR Part 11, EU Annex 11, GAMP 5 guidelines and GxP (GMP,GDP,GCP,GLP) standards.
 Good knowledge on risk based approach to Gxp computerized systems.
 Preparation, review and execution of the qualification documents (VP, URS, Design qualification
(DQ), Risk assessment (RA), IQ, OQ, PQ, Traceability matrix (TM), Compliance report (CR), &VR) as
per 21CFR part 11 and GAMP5 guidelines
 Executed and reviewed the application software protocols (ex: LIMS software, ART work manager,
document management system (DMS), report generation software.)
 Develop and implement software development life cycle (SDLC) policies, procedures and test
Methods to meet the QMS.
 Develop, review test protocols, test reports and change control records.
 Preparation and review of SOPs both manufactured and packing machines related to automated Systems
like PLC/SCADA/HMI and server systems (Lyophilizer, Data loggers, Autoclaves, Tunnels, Filling
machines, Inspection machines, Track &Trace etc.)
 Coordinating with user departments and supporting departments in the preparation of qualification
documents.
 Checking the functions like audit trail, print report, alarms, interlocks, data integrity, data
backup & restore (PLC, SCADA, HMI and Server systems), I/O’s, security policy, communication
loss and power failure in accordance with the 21 CFR part 11, GAMP5 and cGMP guidelines.
 Handled the password policy SOP for all manufacturing and packaging computerized systems.
 Participating in house audits, regulatory and customer audits.
 Coordinating to conduct audits to qualify/disqualify GMP service providers.
 Coordination with other departments to comply audit observations.
 Coordination in the implementation of policies to comply with 21 CFR Part 11 and EU Annex 11
Regulations.

3. KNOWLEDGE ON:
 Good knowledge on guidelines (21 CFR Part 11 & EU Annex 11).
 Good knowledge on cGMP, GAMP, GxP (GCP, GLP, GDP, GMP) standards.
 PLC programming language (Ladder, Structural and Functional block).
 HMI and SCADA designing.
 Knowledge on maintain server systems
 Handled all automated critical and process instruments like RTDs, pressure transmitters, DP gauges, all
types of sensors, flow/velocity meters.
TECHNICAL (IT) SKILLS:
Programming languages : C, C++ and Visual Basic Application (VBA),
PLC Programming (Ladder Logic and Functional block).
PLC’s known : Siemens, Allen Bradley, Mitsubishi, Omron and Delta.
SCADA : Factory talk view, Wincc, wonder ware in touch and I fix
Operating Systems : Windows and XP.
Communications : RS232, RS485, RJ11,Ethernet, ProfiBus and Mod Bus.
PROJECTS UNDER TAKEN:
Developed and Executed the Protocols like VP, URS,DS, Risk Assessment (RA), IQ, OQ, PQ,
Traceability Matrix (TM), Compliance Report (CR) and Validation Report (VR) Protocols’ for the
Following as per 21 CFR Part11and GAMP5 Guidelines.
Project Name : Laboratory Information Management System(LIMS)
Technologies used : .Net, Oracle
Team Size : 3
Project Description : Laboratory Information Management System [LIMS] is designed and
implementation for Quality Control laboratories. LIMS automates sample management process with
complete traceability of a sample thereby helping users ensure that products are manufactured to the
specifications of both internal and external customers. Which is designed by Caliber offers a
configurable, scalable, high-performance, fully web based, n-tier solution with secure, IP address based
access (accessible only through designated systems).
Responsibilities:
 Executed and Reviewed the IQ & OQ Protocols to comply with 21 CFR part 11 and GAMP5.
 Developed the test cases and test Scripts.
 Reviewed the SOPS such as operation phase of LIMS, Data backup and restore security management
…………………………………………………………………………………………………………………

4. Project Name : Artwork Manager
Technologies used : .net, SQL Server
Team Size : 3
Project Description : Online Artwork Management system use to initiate artworks facilitates online
approvals against the checklist for cross functional teams, acts as repository for artwork set of files with
version controls. Tracks the user actions in audit trial and helps to generate fortnight reports.
Responsibilities
 Executed and Reviewed the IQ & OQ Protocols to comply with 21 CFR part 11 and GAMP5.
 Developed the test cases and test Scripts.
 Reviewed the SOPS such as operation phase of Goose Artwork, Data backup and restore security
management.
………………………………………………………………………………………………………………......
Project Name : Building Monitoring System (BMS) & Report generation
Software.
Technologies used : Wincc Explorer, Java, and SQL Server2008.
Team Size : 3
Project Description : BMS is used to monitor the temperature, relative humidity and Differential
pressure of rooms which are located in manufacturing block. This is mainly used for alert the user in case of
OOS excursions and log the every minute data for temperature, Relative Humidity and differential pressure.
Report generation software is used to take reports such as historical report, trend Report and alarm report
and audit trail report.
Responsibilities
 Preparation, Executed and Reviewed the IQ & OQ protocols to comply with 21 CFR part 11 and
GAMP5.
 Developed the test cases, test Scripts and acceptance criteria.
 Developed & executed the Risk Assessment, Design Qualification, Compliance Report, Traceability
matrix and Validation report.
 Reviewed the SOPS such as operation phase of BMS, Data backup and restore Security management.
…………………………………………………………………………………………………………………..
Validated the Computerized systems as follow and made it Compliance state in accordance with
regulatories
Manufacturing equipment’s : Vial washing machine, Tunnel, Filling, Sealing, Auto tray
Collection, Autoclaves, Mixing vessels and Lyophillizer.
Utilities : Generation & Distribution of PW water, Generation & Distribution of
WFI (MCDW), Pure steam generators.
Packing Equipment’s : Vial Labeling Machines, Track & Trace, PFS blistering machine,
Stability chambers and Online check weigher, Auto cartonators,
Auto injector assembly machine, Brevity (optical inspection machine)

5. ACADEMIC CREDENTIALS:
Course Year of pass out Board/university percentage
Masters [Electronics and
Systems design]
2010-2012 Andhra university 84 
Graduation[M.E.Cs] 2007-2010 Andhra university 81 
Intermediate[M.P.C] 2005-2007 Board of Intermediate Education 78 
S.S.C 2004-2005 Board Of Secondary Education 80 
ACHIEVMENTS:
 Received gold medal in under graduation as stood first in class.
 Got all India 37th rank in AURPG set.
STRENGTHS:
 Excellent grasping capability and understanding the concepts clearly.
 Ability to adjust the situation.
 Sense of Responsibility and very hard worker.
 Willingness to work independently and also as a member of team work.
 Strong oral and written communication Skills.
PERSONAL PROFILE
Father’s Name : K Nagaraju.
Mother’s Name : K Kumari
Date of Birth : 05th jun 1989.
Marital status : Un married.
Language known : Telugu, English & Hindi.
Permanent Address : Bhimavaram, West Godaware (dt), A.P.
I hereby declare that all the information furnished by me is true with best of my knowledge.
Thanking you.
Date: K Madhu Krishna Raju
Place:

6. Project’s Done at Gland Pharma Ltd from Jun 2013 to Till Date
Sr. no Project’s Equipment/Software/ Excel
1
 Purified Water Generation and Distribution (PWD)
 Water For Injection and Distribution System
(WFID)
Equipment(PLC,HMI)
2
 Vial washing machine
 Vial Tunnel & Filling machine
Equipment(PLC,SCADA, HMI)
3
 Vial Sealing
 Vial Tray Collection
Equipment(PLC, HMI)
4  Auto claves Equipment(PLC, SCADA, HMI)
5
 Data logger.
 Vessels (Mixing & filing).
Equipment
(Micro controller,HMI)
6  Track & Trace System Equipment (HMI)
7  Stability Chambers
Equipment
(Microcontroller, SCADA, HMI)
8  Vial Labelling M/c Equipment(PLC,HMI)
9  Lyophilizer Equipment(PLC,SCADA,HMI)
10  Excel Sheet Validation Excel Sheet Validation
11  Building Monitoring System (BMS)
Equipment(PLC)
and Software (SCADA)
12  Particle counting system Application software
13  Art Work Management Software Software
14  LIMS Software (5 Phases) Software