IT Compliance and Integrity Specialist

2 weeks ago

Bengaluru, Karnataka, India beBeeValidation Full time ₹ 6,00,000 - ₹ 8,00,000

Job Overview

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The role of IT Validation and Compliance Specialist I is to ensure the integrity and compliance of computerized systems within a pharmaceutical industry setting. This involves performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with the company's Quality Management System (QMS). The ideal candidate will have experience in IT validation and compliance, as well as strong analytical and problem-solving skills.

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Responsibilities

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  • Performing CSV/CSA activities in line with QMS
  • Defining risk-based validation strategies and executing them in accordance with QMS
  • Acting as an SME for validation activities and executing the validation strategy in Agile and V Model environments
  • Defining test strategies, managing test execution, reviewing, and reporting in line with Software Testing Life Cycle (STLC)
  • Handling validation deviations and performing CAPA and RCA using 5 Why or similar approaches
  • Participating in audits and inspections, identifying solutions to compliance gaps, and providing compliance consulting for IT activities
  • Managing end-to-end service delivery, ensuring services are delivered in compliance with internal and external requirements
  • Developing training materials related to business process CSV and CSA
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Requirements

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To be successful in this role, the ideal candidate will have:

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  • Bachelor's or Master's degree in a relevant field with a minimum of 6+ years of experience in a service-based organization/pharmaceutical industry, preferably in the IT quality domain
  • Industry-recognized ITIL and ISO quality management certification
  • Minimum 4 years of practical experience in GxP areas, with exposure to regulatory affairs and 2+ years of performing Root Cause Analyst (RCA), CAPA, and other relevant IT quality activities
  • Experience in Risk Assessment (IT RA, Quality, Functional, DI, Supplier) and Test Management tools such as HP ALM
  • Experience with both waterfall and Agile methodology, supplier assessment, deviation handling, change management
  • Good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11
  • Expertise in performing validation activities for complex projects and ability to represent the company in relations with users and external stakeholders
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Why Join Us?

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Join us in our mission to make a life-changing impact on patients around the world. As a global healthcare company, we recognize the importance of collaboration and diversity in achieving our goals. We offer a dynamic work environment that fosters innovation, creativity, and continuous learning.

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How to Apply

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To apply for this exciting opportunity, please upload your CV online. We look forward to hearing from you

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