Industry: Pharmaceutical
Functional Environment: Project Management structure, QC
Methodology: Prince2
Technical Environment: Laboratory
Context & Objectives
Client requested support in setting up a Project Management structure to identify and coordinate activities for an organisational change project within a laboratory environment ensuring compliance with pharmaceutical guidelines and controlling delays towards the supply chain process.
Approach & Solution
• Review principal changes to their laboratory system to ensure compliancy with FDA guidelines
• Provide operational coaching and benchmarking to QC Team Leaders
• Coordination & allocation of resources in preparation for an FDA audit
Results & Added-Value
• Implementation of a Prince2™ based Project Management structure that provided a periodic review of deadlines and deliverables
• Extended mapping of current activities that enabled creating an action plan for changing the organisation and effectiveness of their QC process
