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CSV Project Manager IDEALLY WITH LABX/CHROMELEON EXPERIENCE

CSV Project Manager IDEALLY WITH LABX/CHROMELEON EXPERIENCE

Posted 27 April by Guidant Global
Easy Apply Ended

Project Manager

Edinburgh

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.

Duties -

  • 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.

SKILLS REQUIRED

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

Guidant is acting as an Employment Business in relation to this vacancy.

Required skills

  • CSV
  • PROJECT
  • LABX
  • CHROMELEON
  • PHARMACAUTICAL

Reference: 42566721

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