CURRICULUM VITAE (CSV)

Suresh Babu Bandi

CAREER OBJECTIVE
Looking ahead for a bright professional career in a challenging that enhance my knowledge
and career, as I help the organization meet its goals with a persistent endeavor to fulfil
responsibilities with complete devotion and honesty.

PROFESSIONAL SUMMARY
• A complete 3.0 year’s of experience in the areas of Computer System Validation.
• Hands on experience in performing validation of Labware LIMS 7.0 (Modules: GLP,
LOT, ICM, AQM, MM) as per GAMP5 V-Model for regulatory requirements.
• Hands on experience in performing validation of SAP ECC 6.0 (GxP Modules such as PP,
MM, QM, SD), SAP UAM (User Authorization Management) and developing
deliverables as per GAMP5 V-Model.
• Hands on experience in SaaS – cloud-based applications such as SAP UAM, LIMS.
• Hands on experience in performing validation of Lab equipment software’s like
Empower3, Enviro (Stability Chamber), tiamo (KF/Auto Titrator), TOC Analyser, UV
Win Lab (UV Spectrophotometer), Stability Chamber, MCP Desktop (Polarimeter),
LabX, Topspin(NMR Spectroscopy).etc.
• Hands on experience in Verification and Validation of the computer system starting from
preparation of Validation Plan, Gap Analysis, Risk Assessment, Traceability Matrix, IQ,
OQ & PQ Protocol and Validation Report as per the classification of GAMP 5, USFDA
guidelines and Good Documentation Practice.
• Perform periodic compliance review of IT systems in GxP Environment.
• Extensive knowledge on the GxP disciplines and 21CFR Part 11, EU Annex 11.
• Strong in concepts of Testing Life Cycles like V-Model.
• In depth knowledge of Computerized Systems Validation, System Development Life
Cycle (SDLC), General Principles of Software Validation.
• Sound knowledge in designing Test Cases and executing Test Procedures.
• Able to Test the Documentation and Good Documentation skills.
• Quick learner with an ability to rapidly achieve Organizational Integration.
• Excellent Communicative, Interpersonal, Intuitive, Analysis and Leadership skills.
EXPERIENCE SUMMARY
• Present Working as a Computerized System Validation Executive in Instrumentation
and Control Solution on Pay Roll from November 2020 – Present.

• Worked as Quality Analyst in Precission Engineering Products from June 2019 – May
2020

ACADEMIC SUMMARY
• Completed Bachelor of Technology (Mechanical Engineering) from JNTU Kakinada
in May-2019.

TECHNICAL SKILLS
▪ Computerized System Validation (CSV)
▪ Clients Served: Piramal Pharma Solutions, Casper Pharma Pvt.Ltd, BE Pharmaceuticals
Pvt Ltd and Lupin Limited.
▪ Technical Documentation: As per GxP, GAMP 5 Guidelines, 21 CFR Part 11.
▪ Software Testing Tools/Approach: Agile Methodology, GAMP5 V-Model.
▪ MS Office Suite (Outlook, Word, Excel, PowerPoint and SharePoint)
▪ Operating Systems: Windows Server’s and Windows Operating Systems.

RESPONSIBILITIES
• Reviewing, Developing, and maintaining GAMP lifecycle documentation.
• Completing 21 CFR Part 11 compliance assessments of laboratory and manufacturing
systems, Including remediation and validation of deficient systems.
• Coordinate the activities of engineering, QA, QC, and contract staff.
• Prepare and review Project Validation plans, & other major system documentation to
ensure consistency with CSV Policy & system life cycle SOP.
• Involved in analysis and collection of requirements for validation activity of computer
system by mutual discussions with the stake holders.
• Create Software Validation Life cycle documents. (GxP assessment, User Requirement
Specification, Functional Specification, Risk assessment, Validation plan, Test Plan, Test
Protocol, Validation report, System acceptance).
• Support during development and planning of CSV associated activities and train involved
personnel on related SOPs, and quality system procedures.
• Re-validation of the Application systems after application upgrades to comply with
regulatory guidelines and compliance requirements.
• Preparing, Reviewing & Update Periodic review report, document review that occurs
periodically to evaluate whether a computer system remains in Validation state.
• Preparation and Review of IQ/OQ/PQ Protocols and Test Cases, associated outcomes.
• Performed CSV of QC Analytical Instruments like KF Titrator, Auto Titrator, UV, TOC,
FTIR, Polarimeter, Thermo Lab Incubators, Stability Chambers, NMR, AAS and HPLC,
GC etc.
• Performed CSV for SAP ECC 6.0 Enhancement Package 7 and SAP UAM as per GAMP5
guidelines.
• Performed CSV for LabWare LIMS 7 as per GAMP5 guidelines.
• Performed CSV for DCS as per GAMP5 guidelines.

PERSONAL DETAILS
Full Name : Suresh Babu Bandi.
Father name : Ram Babu
DOB : 29-08-1997
Gender : Male
Marital status : Unmarried

Languages known : Telugu, English, Hindi.

Permanent Address : #1-58, Koniki, Inkollu (Mndl), Baptla (Dist),

Andhra Pradesh – 523167.

DECLARATION
I do hereby declare that the above information stated is true, correct, and complete to the best
of my knowledge and belief.

(SURESH BABU BANDI)