Technology Compliance Specialist - CSV & Data Integrity Lead

MSD Malaysia; Dublin; Hybrid; EUR 70,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

VISA Sponsorship

Relocation assistance

Job summary

Our Company in Ireland's Dublin Biotech facility seeks a Technology Compliance Specialist to ensure computerized systems comply with regulatory standards. The role covers CSV, SDLC, data integrity, IT security, and regulatory readiness across the DMO and site operations.

Ideal candidates hold a technical degree with 3+ years of CSV experience in a GxP environment and strong cross-functional communication skills to influence stakeholders at all levels.

Qualifications

• Requires degree in a technical field and 3+ years in CSV within a GxP setting.
• Strong knowledge of CSV, data integrity, SDLC, and regulatory compliance.
• Experience collaborating with quality, IT, and manufacturing functions.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, and IT Security policies.
• Lead change controls, periodic reviews, access management, and incident investigations.
• Support audits and regulatory inspections and documentation management.
• Act as SME for DMO validation processes and risk management.
• Maintain inspection readiness through mock audits and corrective actions.

Skills

CSV Knowledge

GxP Compliance

Data Integrity

Stakeholder Mgmt

Education

Degree in Science/Engineering/IT

Job description

Our Company in Ireland's Dublin Biotech facility seeks a Technology Compliance Specialist to ensure computerized systems comply with regulatory standards. The role covers CSV, SDLC, data integrity, IT security, and regulatory readiness across the DMO and site operations.

Ideal candidates hold a technical degree with 3+ years of CSV experience in a GxP environment and strong cross-functional communication skills to influence stakeholders at all levels.