IT Compliance Advisor 2

4 days ago

Bengaluru Karnataka, India IQVIA Full time

**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

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