|Job Title:||Validation Engineer|
|Contact Name:||Catherine West|
|Job Published:||February 07, 2017 09:03|
- Key Team member for the following functions within the Quality Department at the Ireland site:
- Process Validation
- Facility Validation
- Software Validation
- Equipment Validation
- Support and contribute to a Quality culture based upon risk management, process mastery, data-driven analytics and goal-oriented performance accountability.
- Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements e.g., EU IVDD, HPRA, FDA, Health Canada, etc.
- Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations.
- Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs) for functional areas under responsibility.
- Process ownership of Validation Systems.
- Ensure clear and unambiguous requirements for validation activities
- Provide and support validation resources for cross-departmental projects; manage these resources within a defined project management framework.
- Ensure that all validation protocols and reports meet the requirements of the Quality Management System
- Prepare, maintain and review Quality System documents relating to validation.
- Support product and facility inspections.
Qualifications / Experience
- Primary degree qualification in a science, engineering or business discipline.
- Minimum 2 year experience in in vitro diagnostics or related industry.
- Validation protocols and reports.
- Project management of cross-functional teams.
- Building and leading effective teams, and highly motivated individuals.
This role is urgent! Please get in contact if you would like to have a chat about this future opportunity on 02033273072 or email me at firstname.lastname@example.org.
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