Montash have been engaged by a FTSE 3 Company to source an IT Project Manager, specializing in R&D within a Pharmaceutical/Medical Device/Life Science enviornment to manage a variety of initiatives to extend the use of existing IT systems and to deliver new systems.
After a recent reorganisation, various business processes need to be aligned and critical IT systems extended to ensure good practice is applied to all scientific, product data and content management across the group.
The client's products must comply with a range of market specific regulations, and data traceability and provenance is paramount. The client apply the same computer systems validation principles used throughout the Pharma and other life science industries.
Processes- Managing a team of business SME's and the assigned IT Business Analyst through the design and implementation of business processes based on GxP
Technology- Manage the roll out of the following existing systems to a new group within R&D
-Master Control Enterprise Quality Management System
-Sharepoint Content Management
-Waters NuGenesis Scientific data management/ELN
-Manage the delivery of a centralised CAD system to enable secure, controlled management of product drawings
- Direct work experience in a project management capacity, including all aspects of process development and execution
- Project Management Qualification (Ideally Prince2)
- Experience of delivering IT Systems into a Pharma, FMCG or Life Science Environment
- An understanding of the requirements of Computer Systems Validation (GAMP5)
- An understanding of the requirements of ITIL
- Work experience on infrastructure related projects
Nice to Have Skills
- Analytical Labatory Processes and Systems (LIMS, LES, ELN, Cheminformatics)
- R&D Environment
- Quality Management Processes and Enterprise Quality Management Systems
- Document Management, Training Management, Quality Events (Investigations, CAPA ect)
- Clinical Data Management, Data Standards, Dossiers,CTD.
- Content Managment, Sharepoint
- Implementation of migration to externally hosted systems (cloud ect)
- Implementation or major refresh of server infrastructure