Process Validation Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The network of drug substance manufacturing sites includes St. Louis, USA, Lengnau, Switzerland, Groningen, Netherlands and Brisbane, Australia. The success of the network relies on each site to introduce and validate commercial processes, remaining compliant with international quality requirements as defined by TGA, FDA, EMA and other regulatory agencies as applicable.

You will lead Process Validation (PV), Cleaning Validation and Continued Process Verification (CPV) efforts for the Brisbane site utilising the lifecycle approach, in accordance with the Site Validation Master plan, client-specific Validation Plans and within the Quality System. As Manager, Process Validation, you will uphold Customer Allegiance (CAS), quality of work (Right-First-Time - RFT) and On-Time Delivery (OTD) for Validation activities while ensuring product quality, robus...