Executing projects such as engineering and qualification of a new facility, preparing a new pharmaceutical product for regulatory submission or giving your quality management system an upgrade to be ready for an FDA inspection, are typical projects you don’t perform every year. Hiring external staff to lead and/or support these projects may therefore be needed due to:
- Lack of specific knowledge and experience with similar projects
- Lack of capacity to execute the project(s) in parallel with your ongoing business
- The need to shorten time to market or accelerate other milestones by providing extra staff or expert knowledge for your high priority project(s)
Whatever the reason, Progress can provide you with customized project / program management to lead your project(s) from beginning to end, or for shorter periods of the project.
Our project managers are Prince2 certified and will utilize these tools where appropriate for your project. Our consultants combine advanced project management skills with a strong technical background in one or more of Progress’s fields of expertise; Engineering and Commissioning & Qualification, CMC, and Quality.
Depending on your needs, the emphasis will be on project management services, e.g., leading the project team, ensuring timelines and deliverables are met, safeguarding scope and budget and managing stakeholders. When requested and where needed the consultant will also bring his/her technical expertise to the project.
We can support you in the following project roles:
- Program manager
- Project manager
- (Sub)Project team lead
- Project manager assistance (PMO support)
- Team members, such as SME’s and/or representatives from Analytical development, Process development, Manufacturing, QC or RA
- QA project officer ensuring compliance within the project deliverables
Some examples of typical projects our project managers have executed are:
- Feasibility and basic design studies
- Commissioning and Qualification of new or upgraded facilities or specific equipment such as filling lines, freeze driers, fermenters, etc.
- CMC projects from early stage through regulatory submission
- Technological Transfer projects (both analytical methods and process transfer)
- New Quality Management System implementation
As projects may take several years from initiation to completion our project managers and/or team members will remain available for its whole duration, as well as the aftercare period. Where needed we can also contribute to your project for a shorter period, e.g. by executing a risk assessment and/or performing a design review.