12 ago
|
Vantive
|
Guerrero
Your Role
As the Sr Specialist, IT RA General Apps, you will:
- Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements.
- Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions.
- Lead system validation, testing execution, and change management in a regulated environment.
- Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams.
- Act as the primary liaison between IT, business process owners, and external vendors.
What You'll Be Doing
- System Ownership & Governance
- Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements.
- Implement solutions that align with business needs and regulatory requirements.
- Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records.
- Ensure systems remain in a validated state throughout their lifecycle.
- Functional Business Analysis & Solution Design
- Gather, analyze, and document business requirements, workflows, and process improvements.
- Translate business needs into functional and technical specifications.
- Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.
- Ensure solutions are scalable, compliant, and aligned with Vantive’s digital transformation strategy.
- Validation, Testing & Compliance
- Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards.
- Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes.
- Manage risk assessments, audits, and regulatory inspections related to system validation and compliance.
📌 Senior IT Specialist, Regulatory Systems (Guerrero)
🏢 Vantive
📍 Guerrero