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..

Senior DDQ Engineer

Job Description