CSV & IT Compliance Specialist — Hybrid

MSD Malaysia

Carlow

Hybrid

EUR 70,000 - 100,000

Full time

3 days ago

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Benefits offered by this job

Hybrid work model

Job summary

MSD Malaysia – Carlow site – is seeking a Technology Compliance Specialist to ensure computerized systems comply with global regulatory, validation, cybersecurity, and data integrity requirements across the SDLC. You will provide IT compliance and CSV expertise, manage change controls, access management, audits, and risk assessments, and support inspection readiness and regulatory inspections.

The role offers a hybrid work model and opportunities to collaborate across technical, quality, and

Qualifications

Degree in Science/Engineering/IT or related field.
Minimum 3 years CSV in a GxP-regulated environment.
Strong knowledge of CSV, Data Integrity, SDLC and regulatory requirements.
Ability to collaborate across technical, quality and business functions.
Excellent written and verbal communication to influence stakeholders.

Responsibilities

Ensure compliance with global SDLC/CSV, Data Integrity and IT Security policies.
Execute and maintain compliance activities for computerized systems including change controls, access management, DR, investigations, CAPAs, audits and policy deployment.
Support regulatory audits/inspections and act as liaison for auditors.
Serve as SME for DMO-owned compliance and validation processes; guide validation strategy and risk management.
Maintain inspection readiness through reviews, mock audits, and proactive remediation of gaps.