CSV Specialist - Runcorn
Pharmaceutical CDMO
The Company are looking for a Computer Systems Validation Engineer to develop CSV Engineering systems within Production Operations on a permanent basis.
Key responsibilities:
- Accountability for the development and Validation of Computer Systems/Software Validation Procedures to ensure that current regulatory compliance and company objectives are maintained.
- Act as change owner for all GxP IT systems, including risk identification and mitigation, responsible for tracking changes through to completion.
- Preparing and executing validation protocols, reports and effectiveness reviews
- Provide IT support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance.
- Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of IT systems.
- Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review.
- Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
- Validation planning.
- Represent IT at internal and external audits.
- Work with QA Validation department to ensure alignment between IT compliance processes and site validation policies.
- Prepare operational budget and capital expenditure budget for IT projects.
- Research and implement new technologies.
Knowledge and experience:
- Proven experience in a Pharmaceutical, Life Science or similar environment.
- Proven experience with respect to Computer Systems Validation/5 Years in a sterile environment
- Experience in Trackwise
- An understanding of IT Infrastructure and Networks, and IT Qualification activities.
- An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5.
- An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification, Design, Testing, and Configuration Management.
- An appreciation of auditing IT/IS suppliers with respect to a Software Quality Management System.
- Able to create and execute project work plans and revises as appropriate to meet changing needs and requirements to timelines and to budget.
- An understanding of databases, e.g. Access, and spreadsheets.
Please apply now to be considered ...
