Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9zy2lwcm8vanbnl2pvyl9kzwzhdwx0x2jhbm5lci5qcgcixv0

Validation Engineer

Validation Engineer

Job Title: Validation Engineer
Contract Type: Contract
Location: Dublin
Industry:
Salary: Negotiable
Reference: CW-VA
Contact Name: Catherine West
Contact Email: c.west@sciproglobal.com
Job Published: February 07, 2017 09:03

Job Description

Key Responsibilities

  • 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 c.west@sciproglobal.com.