Summary
Overview
Work History
Education
Skills
Certification
Languages
Additional Information
Timeline
Generic

Niranjan Hirphode

Pune

Summary

  • 3 Years of experience in Pharmaceutical, Manufacturing, Biotech, Drug and Device Manufacturing industry with Software Development Life Cycle, Software Implementation Life Cycle, Change Control Management and implementation of business application.
  • Has gained expertise in all the phases of software and computer system validation according to 21 CFR Part 11 and GxP FDA Regulations.
    Have working knowledge of GAMP V, cGMP, ICH, ISPE guidelines especially in the areas of computer or related systems.
  • Good experience in authoring and reviewing of Validation Plan, Risk Assessment, Specifications (FRS,URS, DS, CS), Validation Protocols IQ/OQ/PQ, Validation Summary Report, SOP's, Protocol Deviation Report, Decommission Report, Periodic Review Report.
  • Have knowledge in key Pharma application like Track wise, Document's and Argus Safety.
  • Excellent Knowledge and experience in Good Documentation Practices.
  • Working knowledge in key pharmaceutical areas like regulatory and R&D information systems, pharmacovigilance, Manufacturing and Safety signal detection systems.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Associate

PwC
08.2021 - Current
  • Developed computer system validation related content, controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized system for project qualification plans and protocols.
  • Authored, reviewed and approved the validation plans, computer validation protocols and reports.
  • Involved GAP analysis, Root Cause Analysis, Corrective and Preventive Actions (CAPA) reporting, handling and closing of identified defects and findings.
  • Ensured the system are compliant with current corporate computerized validation polices and legislative requirements.
  • Ensured all tools, templates and materials are readily available and up to date.
  • Support change management activities for cGMP computer systems (ERP, EDMS, LMS, VLMS) and other related activities.
  • Supported regulatory inspection and internal and partner and implemented corrective actions as needed.
  • Provided computer system validation related response to inspectors/auditors.

Consultant

IQVIA
02.2021 - 08.2021
  • I worked on Oncology therapeutic area or disease state (cardiology, gastroenterology, infectious diseases, rheumatology). And establish and maintain relationships with leading physicians, researchers, and clinicians, referred to as key opinion leaders (KOLs) at academic institutions, hospitals, pharma companies, and others.

Education

MBA - Biotechnology & Pharma

Department Of Management Sciences (Pumba)
PUNE
06.2020

Skills

    • Computer System Validation
    • Validation Lifecycle Management
    • Regulatory Compliance
    • Documentation and Technical Writing
      • Project Management
      • Software Development Lifecycle (SDLC)
      • Software Implementation Lifecycle (SILC)

Certification

Computerised System Validation: The GAMP 5 Approach ECA Foundation & ECA Academy Issued Apr 2024 (In person at Berlin Germany)


Administrative Laboratory Information Management System (LIMS) Course SkillBee Solution Issued Jan 2024


IS0 27001:2022 Lead Auditor


Advanced SCADA-PLC

(By NATIONAL INSTITUTE OF ELECTRONICS AND INFORMATION TECHNOLOGY, CALICUT)



Languages

English
Advanced (C1)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)

Additional Information

Industry Regulations: 21 CFR Part 11, Annex 11, ISO 27001:2022 , ICH, ISPE

Timeline

Associate

PwC
08.2021 - Current

Consultant

IQVIA
02.2021 - 08.2021

MBA - Biotechnology & Pharma

Department Of Management Sciences (Pumba)

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Niranjan Hirphode