Computer Systems Validation Lead (ERP, Supply Chain, Warehouse Management System, Documentation Management) Consultant is required by my Pharma client to Manage the Validation activities to deploy ERP Computerised Systems in EMEA countries.
ESSENTIAL DUTIES AND RESPONSIBILITIES
* Responsible for assuring the Computerised System meets the requirements of the systems users & Regulatory requirements;
* Creating, managing, and /or maintaining the deliverables required by my clients quality systems procedures for the development and validation of the Computerised System;
* Coordinate risk management of new or changed computerised Systems;
* Responsible for oversight of protocol execution with on shore & off shore resources;
* Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures;
* Ensure design review and application acceptance including completeness of Trace Matrix (link among user requirements, functional requirements, design requirements and test plan);
* Communicate and control the adherence to validation standards by the deployment team;
* Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures,...).
* Support the processes to maintain in a controlled state of validation during the entire life cycle of Computerised Systems part of the commercial operation in EMEA
* Minimum 2-3 years of experience in validation industry standards;
* Good knowledge of Supply Chain & Quality processes in the Pharmaceutical Industry;
* Knowledge of Supply Chain Systems such as ERP, Warehouse Management System, Service Management System;
* Knowledge and experience in the following areas:
* Documentation Management using document management tool
* Test Management using Testing tool like HP Quality Center;
* Good communication skills (English Language skills); Excellent communicator (dialogue with stakeholders and off-shore contacts)
* Basic project management skills;
* Able to work in an International environment;
* Travel & Working during week-end may be required
This is a fantastic opportunity to secure a long term contract role in a global Pharma organisation. please send your CV in the first instance and you will be contacted with full role and company information.
Logic Engagements Ltd is a leading provider of IT staff to clients, consultancies and to product suppliers/authors.
Our consultants deliver a highly professional service, always backed up by our team of specialist resourcers who are all experienced in their own markets. This ensures that we fully understand our clients' requirements and our candidates' skills and needs.
If you have the relevant skills and experience for this position we would welcome your application, however please note that we often receive high levels of responses to our advertisements so can only immediately respond to those that are a close match. .
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