Description
IT CSV Analyst - Computer Systems Validation - Regulations - Pharama/Medical/Life SciencesA top global organisation is looking for an IT CSV Analyst to join the Southampton offices.
The successful candidate will have CSV expertise and will deliver new system selection/validation activities.
Accountabilities:
* Ensuring business processes are designed to meet the requirements of relevant good practises (GxP)
* Support the RFP process, solution review and selection
* Validation activities supporting the implementation of a centralised Computer Aided Design (CAD)
* Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS)
* Validation activities supporting the implementation of a centralised Product Stewardship system
* Validation activities supporting the development and implementation of interfaces to/from other global systems (SAP, Data Warehouse, Ticketing System)
* Conducts Vendor Audits
* Regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable
* Coordinates Business Criticality Risk Assessments
* Coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment)
* Develops Validation Plans and Test Protocols to define the approach to system verification
* Develops appropriate test scripts, review results, develop testing summary reports and release notes
Essential skills:
* Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical/Medical Device/Life Sciences industries
* Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)
Advantageous skills and experience:
* Analytical laboratory processes and systems (LIMS, LES, ELN, Cheminformatics)
* R&D Environments
* Product Stewardship or Regulatory Reporting
* Product Lifecycle Management (PLM)
* Clinical Data Management, Data Standards, Dossiers, CTD, eTMF
* Content Management, SharePoint
* Quality Management processes and Enterprise Quality Management Systems (Master Control)
* Document Management, Training Management, Quality Events (Investigations, CAPA etc)
* Management of CAD drawings
* SAS
* PRINCE2