Senior DDQ Engineer

Overview

Our multinational Pharmaceutical client is looking for a talented DDQ Engineer to join their team in Ireland. Provide independent oversight and support for the computerised systems to ensure compliance with regulatory expectations and Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data. Integrity requirements. The DDQ specialist will support several shopfloor systems, including DeltaV, PLC/SCADA systems, OSI PI and MES.

Responsibilities

Duties and Responsibilities:

• Providing independent quality review and approval of system lifecycle
• documentation, such as plans, requirements, risk assessments, protocols and
• reports for new and modified systems.
• Providing independent quality review and approval of system changes.
• Supporting and approving computerised systems investigations and test
• Ensuring consistent approach to qualification, change and deviation
• management across systems being implemented on the project.
• Providing timely and pro-active QA IT support and guidance to facilitate
• project timelines.
• Where required, engaging with QA IT teams from other sites to standardise and
• align approach to computerised systems compliance.

Qualifications

Requirements

• Experience in DDQ/CSV, CSV and/or a similar role in the pharmaceutical
• Working knowledge of relevant regulations and industry standards.
• Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
• Excellent communication skills.
• Project management experience will be an advantage..