CSV Project Manager IDEALLY WITH LABX/CHROMELEON EXPERIENCE
INSIDE IR35 - £70-73PH
Onsite / contract until of October 2021
To role is to be a hands on project manager looking after two critical projects (Installation of Chromeleon/LabX across Edinburgh and Annan sites) and qualification of ~ 30 new laboratory equipment in Edinburgh. Must be able to work within the high standards of cGMP, safety and environmental expectations and legal obligations.
- Able to support the business by generating User Requirement Specifications for Chromeleon/LabX and existing purchased lab equipment retrospectively
- Able to project manage both projects, delivering clear project plans and cost control
- Understand the complexity of IT Systems to work with JM IT project managers to support installation of Chromeleon/ Lab X
- To review C&Q documentation and plans and align to the strategic direction of the sites
- To carry out the C&Q aspects of changes and projects through direction from the Q and V manager/ quality department
- To interact with external customer groups in development and alignment of C&Q strategies and to resolve differences of opinion in a satisfactory and compliant manner.
- To act as a subject matter expert at the site and in support of the Health Division as required, especially as the interface with JM IT.
- To ensure changes to the site IT systems remain in GMP compliance.
- Management: In consultation with Production, Engineering, Development, Compliance and Quality representatives, to formulate a strategy for all projects within remit
- Able to identify critical path items and drive these to completion to ensure project remains on track
- Able to challenge behaviours where areas are falling behind
- Able to run daily and weekly project meetings using various tools to ensure full visibility of the project
- To prepare overarching plans in line with project requirements
- To ensure that C&Q protocols and reports are aligned to latest thinking on delivery of compliant C&Q.
- To perform risk assessments related to C&Q activities including the evaluation of change management activities.
- Assist in qualification of production and laboratory equipment and hardware/software with authority to approve non-critical deviations and give protocol approval.
- Responsible for ensuring new or modified IT systems are qualified appropriately through close liaison with the Business Information Systems group.
- Drive CSV strategy for the site to ensure IT infrastructure is robust
- Liaise with external vendors aligning their activities are aligned with site activities, and able to support reviewing of supplier RAMS for onsite visits.
Experience of C & Q project work in a GMP environment
Experience in computer system validation (CSV)
Project Management Qualification (PMP, PAMP, Agile, Scrum etc) and experience of driving quality projects in pharmaceutical environment
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