Detailed Project design, review and operational readiness (IQ / OQ / PQ) preparations to ensure successful completion and startup.
- Supported the development of a significant PAREXEL Investment in Germany, providing detailed support to enable a smooth transition from an Investment project to an Operational facility. The support incorporated improvements to Processes, People, and Organisation to ensure Operational Readiness of the facility
- Facility startup and approval by regulators, on-time and cost
Operational readiness and Regulatory focus;
- Compliance – Pharma client (site Investment (Germany / TIC 4 mio euro); Develop and execute an operational readiness plan for successful start up, multiple regulatory registrations, complex facility validation.
