Overview
Join to apply for the Senior Specialist IT Compliance role at MSD Ireland. An exciting opportunity to join the Ballydine site as a Senior Specialist in IT Compliance. The successful candidate will be computerised systems validation lead for the site. This role will be within the technical unit, ensuring adherence to policies/procedures and driving continuous improvement with a risk-based, lean approach to computerised systems compliance.
Responsibilities
* Lead/support site and cross-functional teams on computerized system validation and information technology and operational technology (IT/OT) compliance.
* Support Computerized System Digital Validation System Development Lifecycle (SDLC), CSA, Inventory, Change, and Deviation Management.
* Ensure compliance deliverables.
* Represent compliance during audits/inspections and develop audit responses.
* Identify and remediate IT/OT compliance risks; support risk assessments for new tech or changes.
* Support compliance operations in Automation and IT teams.
* Assist local teams with quality/compliance challenges and SOP adherence.
* Monitor deviations/CAPAs and communicate SDLC policy changes.
* Collaborate with compliance groups and other sites to share best practices.
Skills & Experience
* Bachelor’s in Computer Science, Engineering, Regulatory Compliance, or related.
* 5+ years in compliance support.
* Strong knowledge of 21CFR Part 11, EMEA Annex 11, GAMP 5
* Experience managing internal/external auditors.
* Understanding of Pharmaceutical Manufacturing, Quality, and Supply Chain processes.
* Strong stakeholder management and communication skills.
* Strategic thinker, results-driven, self-motivated leader.
* Expertise in Computer Systems Validation, Instrumentation/Automation, Project Management.
* Experience with real-time shopfloor/lab systems integration.
* Exposure to diverse technologies and business process re-engineering.
* Lean Six Sigma Green Belt is an advantage.
Job Details
* Employee Status: Regular
* Relocation: Not specified
* VISA Sponsorship: Not specified
* Travel Requirements: Not specified
* Flexible Work Arrangements: Hybrid
* Shift: Not specified
* Valid Driving License: Not specified
* Hazardous Material(s): Not specified
* Required Skills: Audit Management, Business, Governance Management, IS Audit, Management Process, Quality Assurance (QA), Quality Management, Risk Management, Technical Advice
* Preferred Skills: Not specified
Requisition ID: R361615
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