Description
Validation Lead
We are currently working with one our biggest customers who are a global player in the pharmaceutical industry. The position is based just South of Brussels with a need for an immediate start.
Summary:
To support the Validation activities to Computerized Systems for each assigned project.
Essential duties & responsibilities:
- Responsible for assuring the Computerized Systems meet the requirements of the systems users;
- Creating, managing, and/or maintaining the documents required by quality systems procedures for the development and validation of the Computerized System;
- Responsible for oversight of protocol execution;
- Shall control the Validation Package and shall ensure that all documents contained in the Validation Package are maintained per document retention policies/procedures;
- Coordinate risk management of new or changed computerized Systems;
- 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 team;
- Provide support to the functional team/users for the development of validation deliverables (functional specification, technical specification, system & user procedures,...).
Requirements:
- Minimum 5-7 years of experience in validation industry standards;
- At least 1 year as a validation lead
- Good knowledge of Supply Chain & Quality processes;
- Knowledge of Supply Chain Systems such as ERP, Warehouse Management System, Service Management System is required;
- Good communication skills, fluent in English;
Knowledge and experience in the following areas:
- Documentation Management using document management tool
- Test Management using HP Quality Center
Due to the volume of applications received for positions it will not be possible to respond to all applications and only applicants who are considered suitable for interview will be contacted.
Proactive Appointments Limited operates as an employment agency and employment business and is an equal opportunities organisation.