CSV & IT Compliance Specialist (Hybrid)

Merck Gruppe - MSD Sharp & Dohme; Carlow; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Carlow, Ireland, seeks a Technology Compliance Specialist to ensure computerized systems and data management processes meet global regulatory and data integrity standards. You will provide CSV expertise to safeguard the SDLC, support inspections, and help maintain manufacturing quality.

The role covers compliance across SDLC, data integrity, IT security, and regulatory requirements, with expectation to coordinate audits and act as SME for validation strategies

Qualifications

• Required: Degree in science/engineering/IT or related discipline.
• Minimum 3 years' CSV experience in a GxP-regulated environment (pharma/biotech/devices).
• Strong knowledge of CSV, Data Integrity, SDLC and regulatory compliance.

Responsibilities

• Ensure compliance with Global SDLC/CSV, Data Integrity, IT Security policies and regulatory requirements.
• Lead and perform compliance activities for computerized systems including change controls, access management, disaster recovery, audits, and IT security controls.
• Support regulatory inspections and audits, acting as SME for validation strategies and risk management.
• Maintain inspection readiness through reviews, mock audits, and remediation of gaps.

Skills

Auditing Operations

CFR 21 Part 11

Computer Systems Validation (CSV)

Data Integrity

EU Annex 11

FDA Regulations

Gap Assessments

GAMP

Quality Management Systems (QMS)

Systems Development Lifecycle (SDLC)

System Validation

Communication Skills

Education

Degree qualification in Science, Engineering, Information Technology, or related technical discipline

Job description

Merck Gruppe - MSD Sharp & Dohme in Carlow, Ireland, seeks a Technology Compliance Specialist to ensure computerized systems and data management processes meet global regulatory and data integrity standards. You will provide CSV expertise to safeguard the SDLC, support inspections, and help maintain manufacturing quality.

The role covers compliance across SDLC, data integrity, IT security, and regulatory requirements, with expectation to coordinate audits and act as SME for validation strategies