Vinay Bandil (Gupta)

Operations Associate

Noida, Uttar Pradesh, India8 yrs 11 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

8+ years in CSV and IT Compliance.
Expert in FDA and GxP regulations.
Proficient in validation of critical systems.

Stackforce AI infers this person is a specialist in CSV and IT Compliance within the Pharma and Life Sciences industry.

Contact

vinaybandil002@gmail.com LinkedIn

Skills

Core Skills

Computer System AssuranceComputerized System Validation (csv)Software Development Life Cycle (sdlc)

Other Skills

EU Annexure-11Standard Operating Procedure (SOP)GMPUser access ManagementGAMPPharmaceutical ManufacturingGood Laboratory Practice (GLP)U.S. Title 21 CFR Part 11 RegulationSCADAHMIsManual TestingIndustrial AutomationLaboratory Information Management System (LIMS)AutoCADHTML

About

8+ years of experience in CSV and IT Compliance (Pharma/Life Sciences and Healthcare Domain). I works on PLC, SCADA, DAS, HMI and QC based system to validate the system with the help of V-model, GAMP5, 21CFR part11 and EU Annex11

Experience

8 yrs 11 mos

Total Experience

1 yr 6 mos

Average Tenure

1 yr 8 mos

Current Experience

Cognizant

2 roles

Sr. Associate - Project

Aug 2024 – Aug 2024 · 0 mo · Noida, Uttar Pradesh, India · Hybrid

Analyst-LS (CSV and IT Compliance)

May 2021 – Jul 2024 · 3 yrs 2 mos · Noida, Uttar Pradesh, India · Hybrid

Supported as Operational Quality Manager for different IT applications (GxP & Non GxP)
under Safety, Clinical, Medical & Digital, Data Asset Management, & Regulatory Tower.
Ensured adherence to defined Quality Management Process.
Reviewed & Approved Periodic Reviews for GxP & Non GxP applications.
Responsible for review and approve life-cycle documentation for CSV system by
maintaining the quality, compliance and security standards
Validated the Deliverables for each phase of the SDLC to ensure the quality of the
deliverables by Agile & Waterfall Methodology.
Reviewed corrective / preventive actions and remediation of identified gaps and risk during
quality audits and reviews.
Track the quality metrics/KPI agreed with the customer and publish the report on monthly
basis.
Presented & reported IT Process Compliance on monthly basis.
Participating in required forums, meeting to review quality and compliance of application.
Contributed to third party audit and external audit.
Supports audits and inspections to demonstrate that the projects have been managed in
compliant manner.
Prepared applications for audits / assessments and provided support during audits /
assessments.
Escalated non-compliance and alignment / resolution of fundamental CSV compliance
issues.
Mentored team for Quality, Compliance, and Good Documentation Practices.
Monitored effectiveness of Incident Management, Problem Management and Change
Management and prepared process gap report for any non-adherence.
Ensured the process is followed as defined and the applications remain compliant.
Ensured defect management cycle followed correctly with complete analysis.
Supported organizational operational activities like Resource requirement tracking activity
(end-to-end), Candidate evaluation, department activities, ongoing new/back-fill
requirements data, etc.
Experience in ServiceNow, HP-ALM, Diary, IT360, Proton tools etc

Software Development Life Cycle (SDLC)EU Annexure-11Standard Operating Procedure (SOP)GMPUser access ManagementGAMP+4

Ltimindtree

Specialist-Quality Engineering

Aug 2024 – Present · 1 yr 8 mos · Noida, Uttar Pradesh, India · Hybrid

Supported as IT Compliance Manager for different IT applications (GxP & Non GxP) under Non-Product Software System. Also, Supporting Infrastructure Services and tools.
Responsible for reviewing and approving documents as per CSA Approach.
Implementing CSA approach to validate the system by using Direct/Indirect impact assessment and Requirement implementation method like Custom/Config/OOTB
Develop the test protocols by using the testing methods like Scripted (Robust/Limited) and Unscripted (Objective-Based/Ad-hoc) testing.
Implemented Computer System Assurance (CSA) principles to ensure compliance with FDA and GxP regulations.
Conducted risk-based validation of computerized systems focusing on patient safety, product quality, and data integrity.
Utilized vendor documentation and automated testing tools to streamline validation processes.
Reviewed and approved life cycle documents using ValGenesis, ensuring compliance with GxP and regulatory standards.
Managed and approved change control, incident, and service requests in ServiceNow.

Computer System Assurance

Artech l.l.c.

Validation Associate (CSV)

Jun 2020 – May 2021 · 11 mos · Bhopal, Madhya Pradesh, India · On-site

Experience in overall Life cycle of Computer Systems Validation Prepare and Execute URS/FRS, Design Specification , Installation Qualification (IQ), Operational Qualification, Performance Qualification (PQ), Validation Summary Report (VSR) Experience and knowledge of 21 CFR Part 11, GAMP 5 guidelines especially in the areas of quality critical computer systems application. Qualifications of Manufacturing Systems like Blister, Blender,FBD etc. And also qualified the QC systems like Chromeleon, IR Solutions, Rudolph PC, Stability, tiamo, colorimeter, etc

SCADAHMIsComputerized System Validation (CSV)

Iqvia

CSV Consultant

Aug 2019 – Apr 2020 · 8 mos · Indore Area, India · On-site

Experience in overall Life cycle of Computer Systems Validation Prepare and Execute URS/FRS, Design Specification , Installation Qualification (IQ), Operational Qualification, Performance Qualification (PQ), Validation Summary Report (VSR) Experience and knowledge of 21 CFR Part 11, GAMP 5 guidelines especially in the areas of quality critical computer systems application. Qualifications of Manufacturing Systems like Blister, Blender,FBD etc. And also qualified the QC systems like tiamo, colorimeter, etc

SCADAHMIsComputerized System Validation (CSV)

Sun pharma (instrumentation & control solutions)

Executive - IT and CSV

Jan 2018 – Aug 2019 · 1 yr 7 mos · Dewas, Madhya Pradesh, India · On-site

Computerized System Validation, IQ, OQ, PQ, URS, FRS, SVP, FRA, CS, DS, VSR, SRC, TM, RRA and CSAP Documents preparation of lab, scada, IPC, Server based applications, User Access of SCADA, HMI and IPC. Backup restoration of system like HMI, IPC, SCADA, PLC. Time Synchronization etc

SCADAHMIsComputerized System Validation (CSV)