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  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.


Dynamic IT professional with extensive experience in Computerized Systems Validation (CSV) and IT compliance at Lambda Therapeutic Research Ltd. Proven track record in regulatory adherence and quality audits, coupled with strong change management skills. Adept at leading validation projects and ensuring GxP compliance, driving operational excellence in fast-paced environments.

Dynamic IT Quality Manager with extensive experience at Alivus Life Sciences, specializing in GxP compliance and computer system validation. Proven track record in driving continuous improvement initiatives and ensuring data integrity. Adept at cross-functional collaboration and implementing ITIL processes, fostering a culture of quality and compliance across teams.

Over 11 years of experience in pharmaceutical industry with extensive experience in Pharmaceutical Qualification & Validation, Laboratory Software’s, ERP and Industrial Automation (SCADA, HMI and PLC Programming), Data Integrity and cGMP Compliance. Possess wide knowledge of US, EU and Indian Regulation. Proven record of accomplishment in handling large projects relating to Validation and Compliance. Carries out responsibilities in accordance with all GMP and safety requirements, SOPs and company policies and procedures. Effectively communicate with project teams and client stakeholders to meet project goals and objectives. Able to manage project outcomes by identifying, minimizing and mitigating risks. Strong leadership skills with the ability to motivate and inspire colleagues, with diplomacy.

Shanjitha S

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CSV Analyst - ITQA

Senior Executive

Education

Master of Technology - Biotechnology

Bachelor of Technology - Biotechnology

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CSV Analyst - ITQA

Senior Executive

Master of Technology - Biotechnology

Bachelor of Technology - Biotechnology

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