Systems Validation Analyst, R&D - multiple roles
Montash have been engaged by a Global FMCG organisation, who require a Systems Validation Analyst, R&D for a 12-month contract based in Southampton.
We 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.
- 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)
- Validation activities supporting the rollout of Waters NuGenesis Electronic Lab Notebook to meet NGPs evolving requirements (Validation of Template ELN development, code review, Unit Testing, Functional Testing)
- Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS) including change and configuration management
- 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)
If you are available for a new contract position, please get in touch with me on 0207 014 0239 or email me on Ashleya@montash.com