Montash have been engaged by a Leading FTSE 3 Company to source an IT Computer Systems Validation Analyst for an initial contract running until the end of the year with chance of extension. it is based in Southampton but there will be an need for occasional travel to Cambridge and London.
After a recent re-organisation, there is a need to align business processes and extend quality critical IT systems to ensure good practice is applied to all scientific and product data and content management across the group.
Their products must comply with a range of Market-specific Regulations, and data traceability and provenance is paramount. They apply the quality management and computer systems validation principles used through the Pharmaceutical and other Life Science industries.
They are seeking Computer Systems Validation expertise to deliver the validation activities associated with new system implementations and changes required to existing critical systems during this business process alignment and system extension programme.
Accountabilities The role will include, supporting:
* Ensuring business processes are designed to meet the requirements of relevant good practises (GxP) - with special focus on Data Lifecycle Management Process including interface to 3rd Parties
* Review and approval of supporting Standard Operating Procedures ensuring alignment with Quality Policies, GxPs and IT Validation Policies
* Validation activities supporting the implementation of a centralised Computer Aided Design (CAD) system to enable secure, controlled management of product drawings (Dassault SolidWorks, PaaS)
* Compliance activities supporting the rollout of quality management processes
* Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS) including change and configuration management
* Training the user community (and 3rd Parties) in Validation and Testing Processes
* Coordinate Users through Testing of new/changed systems and associated processes
General Role Profile
* Responsible for ensuring that documented evidence exists to provide a high degree of assurance that the operation and maintenance of all R&D systems meet the required standards and Regulations.
* Participates and supports Demand, Delivery and Service activities.
* 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 in conjunction with Business Users, Business Analyst, Application Analysts.
* Review test results.
* Develop Testing Summary Reports, Release Notes.
* Support Change and Release Management.
* Maintain the Good Research Practice policies and procedures.
* Develops system Operating Procedures.
Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical / Medical Device / Life Sciences industry
Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)
Nice to have/bonus skills
- PRINCE2 Practitioner
- Experience in any of the following areas would be an advantage:
- analytical laboratory processes and systems (LIMS, LES, ELN, Cheminformatics)
- R&D environments
- 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
- Scientific data analysis tools (SAS)