Quality Assurance IT

Client: Global Pharmaceutical Company
Location: Carlow, Ireland
Start: January 2020
Duration: 12 months

Successful candidate will join the Quality Assurance IT team to provide independent oversight and support for the Computerised Systems being implemented and modified as part of the site expansion project.

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 deviations.
• 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.
• Ensuring compliance with regulatory expectations and company Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber Security and Data Integrity requirements. T
• Support a number of shop-floor system, including DeltaV, PLC/SCADA systems, OSI PI and MES

Qualifications

• Min. 4 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
• Working knowledge of relevant regulations and industry standards.
• DeltaV, PLC/SCADA, OSI PI and PAS-X experience will be an advantage.
• Project management experience will be an advantage.

Please contact Urszula Kaldi on +44 (0) 203 868 1009 or ukaldi@planet-pharma.co.uk for more details.