Your Name
Bangalore,Karnataka
Summary
A dedicated and passionate Computer System validation and Compliance Specialist with 10+years of experience in regulatory compliance and auditing. Experienced in developing and implementing effective policies and procedures to ensure compliance with all applicable laws and regulations. Skilled in analyzing and evaluating high- risk areas to ensure compliance with internal and external regulations. Highly organized and detail- oriented with excellent communication and problem- solving skills.
Overview
13
13
years of professional experience
Work History
QA Auditor
IQVIA
02.2019 - Current
- Validation of AETracker tool baseline & client specific dashboards with reference to regulatory requirements & guidelines such as 21 CFR Part 11, EU & GDPR.
- External and internal audit & compliance support & documentation
- Performing qualification & architectural validation of the software tool-AETracker
- Creation of project management related process documentation -SOPs, Templates, work instructions.
- Possessing comprehensive expertise in the document management system known as SmartSolve.
- Providing direction to the team on GAMP5 and pertinent GxP standards, including Data Integrity, 21 CFR Part 11 (Electronic Records and Electronic Signatures), and EU Annex 11.
- Assisting with external and client audits related to validation deliverables, processes, and standards.
- Conducting routine internal compliance audits to ensure the integrity of systems and processes, while maintaining a state of readiness for audits at all times.
- Having a good understanding of and demonstrated experience with Electronic Quality Systems (Change Control, Document Management HPALM, etc.) along with technical understanding of IT infrastructure and cloud based services.
- Worked on SaaS infrastructure and Agile validation models.
- I have implemented process standardization and optimization to enhance departmental efficiency and project outcomes and have received multiple acknowledgements for the same.
- Performed observations and evaluated supporting documents to supplement audit findings.
- Provided detailed documentation on audit findings, facilitating swift corrective action when necessary.
- Conducted risk assessments to determine areas requiring increased focus during subsequent audits.
- Streamlined Validation processes, improving efficiency and reducing time spent on each engagement.
- Ensured compliance with regulatory requirements by performing regular audits and staying up-to-date on industry standards.
Application Delivery Analyst
Novo Nordisk
05.2017 - 02.2019
- Application Worked On: ARISg, agInquirer, agClinical, agHub, agcomposer
- Client: Dompe, Lundback,Vifor,TFS, Abbott,Symogen,Merz and many others
- ARISg: It is the world's leading pharmacovigilance and clinical safety system, with more than 300 companies maintaining their critical drug safety data in ARISg worldwide
- AgInquirer: It is an end-to-end comprehensive medical inquiry handling system that accelerates the full request and-response lifecycle
- AgClinical: is a scalable comprehensive clinical trials management solution (CTMS) that enables life science organizations to plan, track, execute and control activities related to the clinical trials process
- Good exposure of ARIS Global Products on SaaS platform for large and mid-sized pharmaceutical companies that includes validation and production phases of Projects
- Worked independently on several projects with major ones being HRA Pharma, Dompe, Abbott, and Vifor
- Having good exposure on various products of Aris Global such as ARISg, agInquirer, agClinical
- Preparation and Execution of standard documents such as CS, CV, PQ's, OQ's, CV and CS as per the Scope of a Project
Senior Executive
iMEDGlobal solutions Pvt. Ltd.
02.2016 - 04.2017
- Good exposure of Johnson & Johnson Product, such as COCOON and CAMELOT application which includes Testing and Validation in Development and staging environments
- Understanding the country specific workflow for materials for approval process in Cocoon application, preparing the test script for execution, and testing the workflow as per J&J customization & specification
- Technically expertise in Validation Testing in Life Science Domain in compliance with FDA 21 CFR Part 11, EU Annexure-11, GAMP5 guidelines & GxP (GMP, GDP, GCP, GLP) standards for J&J
- Process & Procedure Documentation, Validation Package Quality Reviews, Change Control, 21 CFR Part 11 Compliance
- Good exposure of HP Application Lifecycle Management (ALM) tool for quality assurance features in risk-based test planning and management, cycle management, test scheduling and execution, integrated manual testing and defect management
- Executing the Test scripts (System Testing/UAT Testing) using Defect Management Automation tools HP ALM v12.01 & Bugzilla v3.6.3
- Create and maintain Test Cases within ALM 11 Defect Tracking, Status Reporting, and Resolution within ALM 11
- Maintain Compliance in QA Delivery, ALM 11 Usage and Documentation, Release Delivery and Management
- Ensure adherence to Client's policies and procedures
- Hands on experience in using HP ALM for adhering to standardized QA policies, processes and documentation standards
Application Delivery Analyst
ArisGlobal Software Pvt Ltd
03.2012 - 06.2014
- Good exposure of ARIS Global Products on SaaS platform for large and mid-sized pharmaceutical companies that includes validation and production phases of Projects
- Worked independently on several projects with major ones being HRA Pharma, Dompe, Abbott, and Vifor
- Having good exposure on various products of Aris Global such as ARISg, agInquirer, agClinical
- Preparation and Execution of standard documents such as CS, CV, PQ's, OQ's, CV and CS as per the Scope of a Project
- Process & Procedure Documentation, Validation Package Quality Reviews, Change Control, 21 CFR Part 11 Compliance
- Configuration of standard and customized parameters on safety product as per the project requirements and testing the same
Education
BDS - Dental Surgery
Rajiv Gandhi University of Health Sciences
HS - undefined
Bongaigaon railway higher secondary
Bongaigaon, AssamIntermediate - undefined
Bongaigaon railway higher secondary
Bongaigaon, AssamCertificate - SIX SIGMA GREEN BELT
LSSGD Certification Body
04.2001 -
Certification - Language
English Language Proficiency STEP +
04.2001 -
Skills
- Manage and lead Computer Systems Validation team within D&T and accountable for ensuring computer system validation documentation for process & regulatory compliance including GxP & 21 CFR Part 11
- Develop and maintain computer system validation plans, qualification test protocols, IQ/OQ protocols, traceability matrices, SOP and all other documents within the scope of System Development Life Cycle (SDLC)
- Participate & lead system audits which impact GxP Operations
- Ensure CSV Training material stays current and training of employees, temps and consultant to ensure compliance with our internal process and external regulations
- Working knowledge of regulations for electronic systems validation and data integrity
- Knowledge on Document MAnagement System such as NovoDocs and SmartSlove
- Manage relationships with various stakeholders, give guidance and lead workshops
- Conduct quality audits and ensure adherence to healthcare standards
- Collaborate with development and business to provide regular updates to senior management
- Having exposure in building process related to Quality, Standards, and Policies
- Have worked on preparation or reviewing the CAPA whenever required during system audit, internal and external audits and inspection
- Collaborated with Cross functional teams in problem solving through structured and technical approach
Aspiration
- Looking forward to handling a CSV team independently -guiding team on validation, Industry best practices and regulatory compliance requirements.
- Also interested in managing Quality Management System (QMS) team independently under superior guidance.
Awards
Best Student award- For Community Dentistry, 2010
Best Intern Award- Endodontics, 2011
Star Award -ImedGlobal Solution, 2017
Project Champ Award for Abbott-Arisglobal, 2012
Bronze Award, 2021
Bronze Award, 2020
Spotlight Award, 2021
Bronze Award, 2023
Timeline
QA Auditor
IQVIA
02.2019 - Current
Application Delivery Analyst
Novo Nordisk
05.2017 - 02.2019
Senior Executive
iMEDGlobal solutions Pvt. Ltd.
02.2016 - 04.2017
Application Delivery Analyst
ArisGlobal Software Pvt Ltd
03.2012 - 06.2014
Certificate - SIX SIGMA GREEN BELT
LSSGD Certification Body
04.2001 -
Certification - Language
English Language Proficiency STEP +
04.2001 -
HS - undefined
Bongaigaon railway higher secondary
Intermediate - undefined
Bongaigaon railway higher secondary
BDS - Dental Surgery
Rajiv Gandhi University of Health Sciences