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Home
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Iqvia Biotech
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IT Compliance Advisor 2

IT Compliance Advisor 2

Iqvia Biotech

4 - 6 years

9 - 13 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Process automation CRO Data management Risk assessment Software development life cycle Healthcare Clinical research Life sciences SDLC Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description Summary

Compliance and Validation

Hands-on experience in the role of Compliance and Validation
Well-versed with GxP, GDPR, FDA, Part 11, and standard regulations
Knowledge of 21 CFR part 11, GxP regulations, GAMP 5 guidelines
System validation in alignment with GxP and regulatory requirements
Good knowledge of assessing Traceability gaps, improper verification of requirements, improper attached evidences, and raised observations for each deviation
Hands-on experience in reviewing validation artifacts, and quality reviews

System Life Cycle and Methodologies

Well-versed with System Life Cycle
Hands-on experience with Validation approach, Agile methodology, AIML concepts

Testing/Validation Experience

Exposure in reviewing Test Plans, Test Summary Reports
Development of System Validation Lifecycle documents
Risk Analysis, Validation Plan, Validation Summary Report
Preparation and Review of validation deliverables (Validation plan, Functional Risk Assessment, Requirement Traceability Matrix, Qualification Summary Report)
Good knowledge about the defect life cycle

Tools and Technologies - Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems
Quality Management - Knowledge of Quality Management System (QMS)
Domain Knowledge - Healthcare, CRO, Life Sciences domain knowledge

Good to Have Skills :

SaaS Validation and Process -Familiarity with SaaS validation and process
System Validation
- Analysis and development of System Validation Lifecycle documents
- Risk Analysis of system and requirements.
Compliance and Audits - IT and CSV compliance and audit of third-party vendors, Participation in internal audits and/or regulatory audits to represent CSV and IT compliance.
Vendor Management - Vendor evaluation and qualification
Testing/Validation Process - Knowledge about Testing/Validation process, automation
Software Development Life Cycle (SDLC) - Good knowledge about the SDLC process
Data Management and Risk-Based Approach - Good knowledge on data management, risk-based approach
Documentation - Experience in authoring and improving SOPs, work instructions, and templates

. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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