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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. 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