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  • DUBLIN 2
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  • Job reference number:15320788
  • Client ID:RI/RS 16162
  • Posted on:07-FEB-2018
  • Location:DUBLIN SOUTH
  • Job type:PERMANENT

Validation Engineer. Dublin

Reporting to the Validation Supervisor,you will beaccountable for the following functional areas in the Quality department:

Process, Facility, Software and Equipment Validations.

Key Responsibilities

  • Key Team member for the following functions within the Quality Department :

    • 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, as they apply to the company, 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, (IQ, OQ, PQ, URS etc)

  • Prepare and maintain Risk Assessments

  • 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.

Skills and Behaviours

  • Ability to articulate and gain consensus for the Quality perspective in business decisions; provide effective solutions for key business stakeholders.

  • Excellent verbal and written communication skills

  • Technical writing expertise in validation processes, protocols and reports.

  • In-depth knowledge of validation requirements.

  • Ability to successfully implement change.

  • Strong analytical/problem-solving skills.

  • Ability to collaborate with and influence groups in a positive, team‑based environment.

  • Work with a sense of urgency; be impartial and objective.

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