Requirements
Horizon Controls Group have an
exciting opening for a CSV Engineer with one of our major clients in the pharma
industry.
The successful candidate will
join the DDQ team on a site re -structuring project to provide independent
compliance oversight and support for the implementation of new shopfloor
automation systems and modifications to existing site systems. The DDQ
specialist will ensure compliance with regulatory expectations and company
Computer Systems Validation (CSV), System Development Lifecycle (SDLC), Cyber
Security and Data Integrity requirements. The DDQ specialist will support a
number of shopfloor system, including, DeltaV DCS systems, PLC/SCADA systems
and other manufacturing systems.
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
DDQ support and guidance to facilitate project timelines, including close
collaboration with the technical and business units.
· Where required, engaging with
DDQ teams from other sites and capital projects to standardise and align
approach to computerised systems compliance.
Experience:
· Min. 5 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.
· Proven ability to meet
timelines, prioritise tasks and engage with stakeholders.
· Excellent communication skills.
· Project management experience
will be an advantage.
· DeltaV DCS experience
essential.