Soumya Pb
csv analyst
Bangalore,KA
Summary
- To pursue the carrier in learning and working on the best practices in computer system validation compliance with regulatory environment.
- Good exposure on Life cycle documentation and responsible for tracking, monitoring and controlling validation process.
- To ensure timely and cost-effective delivery of the system to the business users /customers.
- Conducting of handshake meetings with relavent stakeholders at the initial stage of the project to summarise the project scope and timelines .
- Having good experience in the FDA and EMA guidlines.
- Having good exposure in vendor audits .
- Having experience in data privacy and security .
- Responsible for the preparation of validation plan/Quality plan, validation summary reports.
- Review of all SDLC documents throughout the project and maintaining the documents in DocNav and DMS applications.
- Conducting daily meetings with all relavent stakeholders to update the project status and identifying the action items to work.
- Review of test scripts and test runs ,Test defects in HPLAM.
- Ensure the Computerized system validation for various applications following GAMP 5, EU Annex 11and 21 CFR part 11 guidelines.
- Review of High Level risk Assessment includes GxP Assessment and GAMP categorization, criticality assessment, ERES Applicability Assessment etc. Qualification Documents and Test Specifications (DQ, IQ, OQ scripts).
- Traceability Matrices, Gap assessments and Risk Analysis Validation Reports, Change Controls/ Events / Deviations.
- Experienced in Periodic review to confirm that the computerized system remains in a valid state and are compliance with regulatory standard requirements.
- Prepare and Review Data Migration Plan, System Retirment Plan with their summary Report.
- Having knoeledge in agile methadology and waterfall methadology
- Experience in preparation, review and approval of Validation protocols and validation documents, traceability matrix and validation summary reports.
- Expertise in reviewing and approving of key deliverables Supplier assessment, Validation plan, User requirement specification (URS), Functional requirement specification, Design specification and Configuration specification in compliance and conformance against with validation guidelines.
- Expertise in verification and evaluation of security management Electronic records and Electronic signatures deliverables as per 21 CFR Part 11 regulatory requirements.
- Experience in Incident, Defect, Deviation, CAPA, Change control and Risk Management & mitigation plan as per Quality Management System.
- Experience in review and approval of audit trail as per the internal procedure. Excellent knowledge and Working Experience with Preparation, Execution and Review of QLMS (Quality Laboratory Management System) software validation.
- Excellent knowledge and Working Experience with Preparation, Execution and Review of Learning Management System (LMS) software validation. Implementing and ensuring 21 CFR Part 11 Compliance.
Overview
5
5
Years , 9 month of professional experience
3
3
Language
Work History
CSV Analyst
Biocon
12.2022 - 11.2024
- A dynamic industrial experience with 3 years in handling of Computer system validation and QMS and 2years 9 month in handling laboratory equipment
- Knowledge in risk management process and compliance,Deviation and CAPA.
- Strong understanding in 21 CFR pat11,GXP, GAMP5
- Having knowledge in agile methodology and waterfall methodollogy
- Familiar with HPALM tools and involve in regular interaction with stakeholder
Analyst
Medreich Pharma Pvt. Ltd
banglore, karnataka
11.2017 - 09.2022
Education
M.Sc - Industrial Chemistry
01.2015 - 01.2017
- First class
- GPA: 62%
B.Sc. - CBZ(chemistry,botony,zoology)
01.2012 - 01.2015
- First class with distinction
- GPA: 64%
Skills
Agilent HPLC systems
Auditexposure
- US FDA
- MHRA
Disclaimer
I hereby declare that the above-mentioned particulars are to the best of my knowledge.
Personal Information
- Father's Name: Prahallada.B.V
- Date of Birth: 11/24/94
- Marital Status: Married
Timeline
CSV Analyst - Biocon
12.2022 - 11.2024
Analyst - Medreich Pharma Pvt. Ltd
11.2017 - 09.2022
Kuvmpu university - M.Sc, Industrial Chemistry
01.2015 - 01.2017
Smt.INDIRA GANDHI COLLEGE - B.Sc., CBZ(chemistry,botony,zoology)
01.2012 - 01.2015
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