PAS-X Consultant (MES)

PAS-X Consultant
Contract until end of December 2015

My client is a Global Pharmaceutical company based in Macclesfield, Cheshire. They are looking for someone with previous experience of creating master batch records utilising PAS-X ideally version 316/317. Previous pharmaceutical experience would be advantageous, if not food manufacturing so ideally someone with a manufacturing background.

The Project SMEs are responsible for ensuring they identify the gaps and requirements for the business processes to support the PAS-X system and for executing the data, testing and training tasks to verify manufacturing execution processes are met on behalf of the business.

The responsibilities include:

Business Process

1. Confirm business process definition and ensure business processes have been effectively captured in the business process documentation.
2. Verify business targets and objectives are met by the system design.
3. Effect sign off of Business Process documentation.

Data Conversion

1. Creation of Master Batch records required to replace PI Sheet records in icon.
2. Assist in developing and establishing data reconciliation procedures;
3. Execution of data reconciliation, verification and control procedures.
4. Verification of extracted data from icon.
5. Verification of loaded data into PAS-X
6. Reconciliation of data in PAS-X and production of Data Results documents.
7. Perform sign-off upon completion of data verification and control checking activities.

Testing

1. Review and amend test scripts or create new test scripts for integration and user acceptance testing
2. Co-ordinate Integration Testing
3. Co-ordinate UAT testing by Key Users
4. Execute regression testing activities
5. Perform issues rectification and resolution

Authorisations

1. Determine the appropriate access permissions and limitations within the new PAS-X system ensuring it is important that SOx and GMP requirements are incorporated into the role creation process.

Training

1. Conduct Impact assessment with Change Manager on change to existing business process necessary for a successful system implementation.
2. Identify key users to deliver end-user training in PAS-X and plan training with Change Manager.
3. Validate business readiness as a consequence of training for Go-live with the Change Manager

Post Go Live

1. Develop with Service Introduction Manager effective 1st Level post-implementation support so as to provide end-users with on-going PAS-X support.

Other

1. Ensure delivery and sign off of key deliverables identified in the RACI Matrix.
2. Resolve business issues that impact the ability of the project team to deliver the project goals
3. Ensure business expertise is available to the project team.

To apply to this role, please forward an up to date CV,

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