Summary
Overview
Work History
Skills
Timeline
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Rohit Ranjan

Rohit Ranjan

442, Monte Farm Rd, Mount Laurel,NJ

Summary

Results-driven CSV Lead Consultant with over 18 years of experience in Computerized Systems Validation, Quality Management, and Regulatory Compliance. Proven ability to drive validation strategies ensuring compliance and operational excellence.

Overview

3
3
years of professional experience

Work History

CSV Lead Consultant

White Collar Technologies
11.2022 - Current
  • Dynamic and hands-on validation consultant offering 18+ years of experience in a variety of integrated Life Sciences IT projects with expertise in Computerized systems Validation, Software Quality, Risk and Compliance Management.
  • Strong professional background with various regulations and standards including 21 CFR Part 11, 21 CFR Part 820, 21 CFR Part 211, EMA Annex 11, cGxP (GMP, GCP & GLP), GAMP, ICH, ANSI/ISA-88 (S88), MHRA, ISO 13485 and ISO 9001.
  • Collaborated with the client management team to plan, implement, and drive validation strategies for key validation projects, ensuring compliance with regulatory standards and project objectives.
  • Led the development and continuous improvement of the Quality Management System (QMS), including processes for change control, deviations/non-conformances, CAPA, and internal audits to ensure regulatory compliance and operational excellence.
  • Coordinated with vendors and IT teams to clearly define and confirm ownership of project deliverables, ensuring alignment between vendor and client responsibilities.
  • Conducted training sessions for vendors on Good Documentation Practices (GDP) and execution processes to ensure adherence to Minaris' quality and compliance standards.
  • Provided Computer System Validation (CSV) expertise to support team members in conducting regulatory risk assessments and system categorizations in alignment with GAMP 5 guidelines.
  • Served as the primary resource for the development, execution, review, and approval of equipment qualifications—including laboratory equipment and computerized systems—as well as associated change control activities.
  • Performed risk assessments and 21 CFR Part 11 evaluations for various software systems associated with pharmaceutical equipment to ensure regulatory compliance and data integrity.
  • Authored, reviewed, and approved technical documentation, including IQ/OQ/PQ protocols, summary reports, SOPs, and change controls, ensuring accuracy, compliance, and alignment with regulatory standards.
  • Veeva Vault Certified Administrator

Skills

  • Computer system Validations ~ 21 CFR Part 11 ~ GxP (GLP, GCP, GMP and GDP) ~ Annex 11 ~ SDLC ~ CAPA Management ~ Audit Management ~ Requirement Traceability ~ Deviation management ~ ALM ~ Service Now ~ SAP ECC ~ ECM ~ Veeva Vault ~ Functional Requirements ~ Reviewing & Documentation ~ Software Change Management ~ Team management ~ Waterfall methodologies ~ Hybrid Methodologies ~ Agile scrum methodologies

Timeline

CSV Lead Consultant

White Collar Technologies
11.2022 - Current

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Rohit Ranjan