Within this role you will be responsible for qualification activities for Controlled Temperature Units (e.g. freezers, incubators, walk-in cold rooms) and warehouses in accordance with cGxP, regulatory requirements and industry trends within the frame of Industrial Operations and major capacity expansion and transformation projects for the delivery of highly digitalized and automated suites for the production (upstream, downstream) of drug substance for biologics.
A typical day might include, but is not limited to, the following:
* Generating, executing and/or reviewing master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
* Analysing the results of testing and determines the acceptability of results against pre-determined criteria
* Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
* Reviewing, editing and approving deviation notifications, deviation investigations, and corrective actions
* Reviewing and approval change controls, SOPs, reports and other documentation
* Coordinating with other departments or outside contractors/vendors to complete validation tasks
* Managing projects and prepares status reports
* Providing oversight to contingent workers may be a requirement