Uday Kumar Bandaru is seeking a challenging position in quality assurance where he can apply his 5 years of experience in areas such as quality system management, computer system validation, process validation, auditing, and regulatory compliance. He has a strong technical background and has worked with major pharmaceutical companies on projects involving FDA, WHO, and other international regulatory bodies.

1. Uday Kumar Bandaru
E-Mail: udaybandaru631@gmail.com
Mobile: +91 9963412312
----------------------------------------------------------------------------------------------------------------
Career Objective:
To be a Self-motivated and determined pharmacy post graduate having a great
passion to get into a challenging position, seeking a full-time work where I can apply my
skills and knowledge for the growth of my career as well as entrepreneur.
Summary:
 A passionate Quality Assurance Professional with 5 years of diversified experience in
Quality assurance
 Experiences includes Author and Executed URS/IQ/OQ/PQ Protocols.
 Computer System Validation, Process Validation, Qualification of Equipment and
Process Automated Equipment.
 Sound knowledge on SDLC process.
 Knowledge on Validation Master Plan, Retirement Plans, traceability matrix and
Validation summary reports.
 Knowledge on Regulatory guidelines like 21 Part 11, 210, 211, 820, PIC/S 011, ICH
GCP, ICH Q7, Q10,
 Experience on Track Wise, LMS, LIMS
 Sound knowledge on Data integrity issues, incident, deviation, change control
handling, manufacturing activities, CAPA management
 Sound knowledge on e-Batch manufacturing record
 Successfully handled major audits like FDA, WHO, MHRA, TGA, ANVISA, MCC
Work Experience:
Organization Designation Duration Reporting Pattern
Strides Shasun, Bangalore
(Global QA)
Sr. Executive Feb 2016 - Till date
Associate Vice President- QA
Dr.Reddy’s labs, Hyderabad
(USFDA Approved)
Associate QA
June 2014 – Feb 2016 Manager- QA
Hetero labs limited, Jadcherla
(USFDA Approved)
Jr Officer June 2011 – June 2014
Assistant Manager-QA
Experience in STRIDES SHASUN (GQA – global audit and compliance):
 Planning and executing internal audits globally
 Participating in announced and unannounced audits and providing audit reports in
Track wise
 Review of Audit response for its adequacy and ensuring appropriate CAPA in Track
wise
 Subject matter expert for QMS (Track wise)
 Review of Deviations, Change control,CAPA in Trackwise
 Monitoring QMS tasks in Trackwise for timely completion and escalating overdue
records in MRC

2.  In co-ordination with IT team developed Trackwise internal audit module for
reporting
 Providing periodic training on handling QMS records in Trackwise for users
 Developed stepwise video manual for reporting and handling Internal audits in
Trackwise
 Responsible for preparing Internal Audit metrics for presenting in MRC
Experience in DR.REDDY’S Labs (CSV & Internal Audit):
 Identification of areas/ where automation system can be implemented.
 Established continuous process improvement at various levels at the organization
with 21 CFR Part 11 compliance.
 Perform Quality System reviews related to the System Life Cycle documentation and
Change Control that ensures consistency to policies for computer validation.
 Experiences includes Author and Executed URS/IQ/OQ/PQ Protocols.
 Development of traceability matrix, deviation reports, validation summary reports.
 Quality review and writing of SOP, Qualification Protocols i.e. IQ, OQ and PQ for
computer system validation as well and other GMP environment equipment
 Provide technical support, and regulations and standards support to the audit team.
 Responsible for preparing Quality assurance personnel for major regulatory audits
 Training Quality assurance staff on current SOP’s ,Data integrity, current regulatory
scenario and CAPA
 Plan ,schedule, conduct, report internal audit findings
 Raising notifications and complying CAPA
 Responsible for complying Change controls
 Responsible for conducting sessions on internal audit findings with respective area
owners.
Experience in HETERO Labs limited:
 Ensuring cGMP (current Good Manufacturing Practices) and required Standard
Operating Procedures and followed during processing of the drug product
 Execution of Process validation, cleaning validation & Hold time study as per the
protocol, timely collection of stability, control, Periodic, Intermediate, Finished
product samples as per SOP
 Expertise in critical samplings like Vertical sample ,Compaction sample, normal
sampling and swab sample
 In process checks in all the manufacturing processes, reconciliation, Planning and
execution of activities related to IPQA
 In-process Monitoring of critical attributes
 Assure that all calibration/PMP are properly planned, conducted and documented
 Performing AQL
 Dispensing of Raw materials & packing materials
 Carry out Line clearance of Various Manufacturing, Packing Operation & dispensing
activity
 Reviewing BMR & BPR of tablet dosage forms
 Review of process validation protocol before execution of validation batch
 Draft Review of BMR, BPR, Process Validation Protocols, Hold Time Study Protocols
 REVIEW of Process Validation Report, Hold Time Study Report & cleaning validation
report
 Review of cleaning validation report, hold time study report & process validation

3. Education:
 M pharmacy from Pragathi college of pharmacy (JNTU), Janagaon with 76%
 B Pharmacy from Gokul College of Pharmacy (JNTU), Bobbili with 70%
 Intermediate Sri Chaitanya Junior College, Vishakhapatnam with 84.3%
 SSC in Prashanthi Nikethan Mvvs Murthy English Medium High School, Anakapalli
with 82%
HONORS & ACHIEVEMENTS:
 Got appreciations in Crisis Management Team of Hetero Labs Limited
 Got appreciations for active participation in USFDA, MHRA, WHO, ANVISA Audit
 Shikar award for implementation of Air Tube Transfer System in Dr.Reddy’s Labs
OTHER CAPABILITIES & ACTIVITIES:
 Sound Working knowledge on MS office
 Successfully organized Hetero 20 year’s celebrations
 As a captain made our team as champions in CRICKET, Runner up in VOLLEYBALL
PERSONAL DETAILS:
Date of Birth : 23rd August 1989
Gender : Male
Nationality : Indian
Marital Status : Unmarried
Languages known : English, Hindi and Telugu
Permanent Address : S/o Nageswara Rao,
Cheri Bandarupalem (V),
Vadacheepurupalli (P),
Vishakhapatnam (D),
Andhra Pradesh, Pin: 531020
DECLARATION:
I do hereby proclaim that the above-furnished facts are given to the best of my knowledge
and belief.
Uday Kumar Bandaru.