Pas-X Specialist - Application Manager

Description

PAS-X Application Manager


We are currently in search of a PAS-X Application Manager for two PAS-X projects; EBR Next gear and Serialisation. Currently, there are two packaging lines running on the EBR system and the aim is to convert all packaging and formulation processes from paper to Electronic Batch Records (EBR).

The role will involve:

-System tie-ins for formulation and packaging equipment
-Write functional specifications (Functional Requirement Specification/ Business Blueprint, Application Configurations) or outsource if applicable;
-Contribute to EBR and Serialisation projects in the role of a PAS-X specialist.
-Follow and secure Change Management Procedure
-Take on the role of central communicator to the vendor of the application.
-Contribute to Validation Plan, execute OQ, support KU with test (preparation incl. pre-PQ, OQ test, test protocols, test data, acceptance criteria);
-Application configuration management;
-Ensure the application is maintained in its validated state after go-live and is performing to an agreed performance level.
-Maintain meta data (parameters, settings, general master data, log files) (*);
-Maintenance and support of the PAS-X application
-Supporting coordination, optimisation and control of all workflows onsite.
-Work according to on GAMP V, ITIL, ASL, COBIT (best practices);

The successful candidate will:

-Have previous experience of PAS-X system design, configuration management and user management
-Experience of configuration and management of EBR
-Experience of connecting equipment to a PAS-X system
-Strong pharmaceutical background in a BlueChip environment
-Very strong communication skills; ability to work closely with operators, vendors and senior management alike.
-English OR Dutch fluency required.