Job description
Job Title: CSV Compliance Specialist
Location: Barcelona, Spain
Type: Permanent
We are looking for an experienced CSV Compliance Specialist to join a team in Barcelona, working for a leading pharmaceutical client. The role focuses on ensuring that IT systems used in GXP-regulated environments meet strict regulatory requirements, with a strong emphasis on Computer System Validation (CSV). The ideal candidate will work closely with technical teams and senior CSV specialists to ensure compliance across all IT systems, ensuring both documentation and systems adhere to GXP standards.
Key Responsibilities:
Perform CSV documentation testing, ensuring that all relevant system documents comply with regulatory standards.
Collaboration with other teams to conduct testing and validation of systems, documenting all activities in line with CSV requirements.
Ensure that all systems meet GXP IT compliance by guiding end-to-end activities and ensuring the systems are aligned with GXP requirements.
Support the continuous monitoring of systems for compliance, providing detailed reports and supporting audits when necessary.
Participate in risk-based validation assessments, focusing on data integrity and compliance risks.
Key Requirements:
At least 3+ years of experience in CSV documentation roles, specifically within testing and reporting structures.
5 years of GXP IT compliance experience, with expertise in managing end-to-end activities ensuring compliance with GXP requirements.
Proven ability to work within a team environment and report to senior leadership without assuming managerial responsibilities.
In-depth understanding of relevant regulations
Excellent communication skills and the ability to collaborate effectively with technical and non-technical teams.
