ASHVINI REVATHI R
Business and Integration Senior Analyst
Chennai,TN
Summary
Experienced Computer System Validation Expert with almost a decade of experience in life sciences. Ensuring compliance and delivering audit-ready systems.
Total 8+ years of experience in Pharma sector and IT sector (CSV). To author/review Software Validation documents (like: URS, FS, IQ, OQ, PQ, GxP Assessment, Risk Assessment) starting from preparation of Validation Plan, Risk Assessment, Traceability Matrix, IQ, OQ Protocol, Validation summary Report as per the classification of GAMP 5, USFDA guidelines (21CFR Part 11), EU annexure 11 and Good Documentation Practice. Good Exposure on Regulatory requirements of Computerized Systems and sound knowledge of GxP, GAMP 5, EU Annex 11. Strong in concepts of Testing Life Cycles like Waterfall, Agile.
Overview
9
9
years of professional experience
3
3
Languages
Work History
Business and Integration Sr.Analyst
Accenture
12.2019 - Current
- Experienced in all stages of Software development life cycle. This includes generating functional requirements from Client/Business requirements, analysis and design, development, testing and deployment.
- Experience in creating/Reviewing Validation documents across the Validation Life cycle like Validation Plan,Protocols (IQ,OQ,PQ),RTM and Validation Summary Report.
- Knowledge of validation lifecycle keeping in mind the demands of a regulated environment.
- Has Hands on experience in working on Agile Methodology.
- Reviewing the Pre-approval and Post-approval test scripts (SIT,UAT and RT).
- Defects tracking/ documenting & closure.
- Responsible for Reviewing and approval of validation deliverables such as Configuration Specification document, Design Specification document , Requirement Traceability Matrix ,User Requirements Specification (URS) ,Technical Design Specification (TDS).
- Experience on Implementation & validation of SAP 4 HANA Implementation.
- Performing Validation in Agile and Waterfall methodologies.
- Coordinating with Project stakeholders.
- Providing status report to Project Manager on script and document reviews. Managing IQ/OQ/PQ trackers, Defect Trackers.
- Authoring validation deliverables like Validation Master Plan, Summary Report documents, Sprint Completion Reports for Agile projects.
- Review and approval of SIT,UAT and RT Test Scripts.
- Defect logging.
- Tools Used: RQM,RTC,HPALM,JIRA-Confluence, JIRA- Zephyr, JIRA-Xray, Solution Documentation (SolMan), KNEAT.
Senior Validation Associate
IVY Works LLP
09.2016 - 12.2019
- Preparation of GMP documents (VMP, IA, GXP, RA and URS) as per regulatory requirements for Biotech formulation facility.
- Experience in GAMP 5 and 21 CFR Part 11 Compliance.
- GxP Assessment, Data Integrity Check.
- Preparation of Qualification protocols ( IQ, OQ, PQ) as per regulatory requirements for process equipment.
- Risk Assessment, Security & Compliance.
- Standardization of validation documents, Internal SOPs.
- Involved in finding the discrepancies and closing the same.
- Computerized System Validation (CSV) of production systems.
- Receiving comments from different stakeholders for documents and getting pre- and post-approval.
- Preparation of supplementary requalification documents against audit observations.
- Preparation of validation documents including design qualification reports, installation qualification, operational qualification protocols, SOP, maintenance instructions and other validation documents.
- Execution of validation protocols at site.
- IT – Quality and compliance to US-FDA,EU, GAMP 5.
- Experience in working with Multiple pharma clients.
- Preparation of 21 CFR Part 11 Documents-Execution, Compilation and Submission of reports.
- Project: Computer System Validation for Laboratory Systems.
- Systems Validated: Diffrac.Suite 21 CFR Part 11 V7.5,Tiamo,TOC,Pharmspec,32 Karat, Gen 5, Vicell, Vitek, NIS, Perkin Elmer IR Spectrum, Spectra manager, Topspin, Agilent Cary Win UV,Lab solutions UV and IR, Enviro , Erweeka etc…
- Roles and Responsibilities: Preparation of User Requirement Specification, GxP Impact Assessment, Functional Risk Assessment, Functional and Configuration Specification. Preparation and Execution of Installation Protocol and Report. Preparation and Execution of Operational Protocol and Report. Preparation and Execution of Performance Protocol and Report. Submission of Traceability Matrix, Closure of Functional Risk Assessment and Validation Summary Report.
Education
Master of Technology - Biotechnology
Vellore Institute of Technology
Bachelor of Technology - Biotechnology
ARJ College of Engineering and Technology
Skills
GAMP5
Interests
Reading
Listening Music
Cooking
Personal Information
- Date of Birth: 19 December 1991
- Gender: Female
- Nationality: Indian
- Marital Status: Unmarried
Disclaimer
I hereby certify that the information given in my Curriculum Vitae is correct and complete to the best of my knowledge.
Software Experiences
Laboratory Software
Diffrac.Suite 21 CFR Part 11 V7.5,Tiamo,TOC,Pharmspec,32 Karat, Gen 5, Vicell, Vitek, NIS, Perkin Elmer IR Spectrum, Spectra manager, Topspin, Agilent Cary Win UV,Lab solutions UV and IR, Enviro , Erweeka etc…
IT Software
RQM,RTC,JIRA,Confluence,SOLMAN,SOLDOC,KNEAT and HP-ALM
Recognitions
1.Delivering the deliverables efficiently
2.Effective colloboration
3.Best Performer
4.Good Team Player
5.Client Value Creation
6.Respect for the individual
Timeline
Business and Integration Sr.Analyst
Accenture
12.2019 - Current
Senior Validation Associate
IVY Works LLP
09.2016 - 12.2019
Bachelor of Technology - Biotechnology
ARJ College of Engineering and Technology
Master of Technology - Biotechnology
Vellore Institute of Technology
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