CSV Analyst Global Apps (m/f/d)

Job title:

CSV Analyst Global Apps (m/f/d)

Company:

Halian

Job description

As an IT CSV Expert Analyst – Global Applications, you will be responsible for ensuring compliance and validation of non-GMP applications, including clinical and reporting applications, within IT Compliance Solutions team. You will work closely with IT system owners, business stakeholders, and compliance leads to manage validation activities, documentation, and audits.Key Responsibilities

• Lead Computer System Validation activities for assigned changes and projects.
• Define validation approaches and required deliverables.
• Author, review, and facilitate key CSV documentation, including:

? Validation Requirement Assessment
? Validation Plan & Report
? Test Protocols (IQ/OQ/PQ/MQ) & Reports
? Traceability Matrix

• Oversee the sequencing and completion of validation deliverables.
• Coordinate and support test execution with IT and business teams.
• Monitor and document deviations, CAPAs, and related actions.
• Escalate any issues or delays to the IT Compliance Lead.
• Support inspection/audit preparation and defense.
• Serve as the deputy for the IT Compliance Lead on assigned projects.
• Participate in weekly meetings to report progress and discuss activities.

Required Qualifications & Skills? Minimum 3 years of experience in Computer System Validation (CSV) within a regulated environment.
? Strong expertise in validation of pharma applications, including:
? GPVP (e.g., Adverse Event Reporting: Argus, ArisG, Veeva Safety)
? GCP (e.g., Clinical Trial Monitoring: CTMS)
? General Pharma Systems (QMS, Learning, Testing, Medical Applications)
? Experience with compliance/validation of mobile & web applications.
? Familiarity with Veeva systems is a plus.
? Knowledge of cloud platforms (Azure, AWS), monitoring tools, identity & access management, and communication platforms (Office 365, Skype, Exchange) is beneficial.
? Strong stakeholder management, communication, and negotiation skills.
? Ability to work autonomously with a proactive and problem-solving mindset.
? High attention to detail and ability to handle compliance documentation effectively.
? Fluent in English (mandatory); French is a plus.#LI-SD2

Expected salary

Location

Bruxelles

Job date

Tue, 25 Feb 2025 23:45:06 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.