PMC and Global Risk Management for pharmaceutical sites

Project management Life Sciences France

Context and challenges

Since 2010, this client, a leader in the pharmaceutical industry, has been developing and industrialising new processes for the production of active ingredients with cortisone (UCI). It has required major research and development investment and the revamp of several industrial sites.

The project (>150 M€) has an impact on the production of 13 active ingredients (corticoids) with a new biochemical pathway, causing a high level of technical and regulatory complexity.

This client manages numerous sub-projects and needs to secure critical milestones. The client wished to subcontract the development of a risk management processes, as well as reinforce the scheduling management and cost processes for all the activities.

The client has appointed Assystem to assist with the management of one of its projects, in the context of PMC contract.

Logo Assystem Care

Project scope

A director from Assystem Care has joined the project management team to complete the following tasks:

  • Develop and control the global planning, cost reporting and physical progress, monitoring of all strategic activities: R&D, QA / QC, Regulatory affairs, Engineering, Commissioning Qualification and Validation, Supply Chain, EHS
  • Train and deploy Assystem Global Risk Management as a project control methodology
  • Lead six permanent groups for risk and project reviews
  • Lead scheduling and risks steering committee reviews for industrial sites

Client benefits

The methodology and the frequency of project risks reviews (> 200 reviews concerning twelve critical sub-projects) allowed rigour and anticipation in deadline and global costing management.

The client expressed appreciation during many scheduling and risks reviews that involved all the major stakeholders at top management level.

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