JOB OFFER

JOB DETAILS

Title:
QA Validation Engineer
Location:
Mayo
Job Type:
Mayo

QA Validation Engineer

GerTEK Project Management & Technical Services are hiring for an experienced QA Validation Engineer to join our team.

Responsibilities

  • Management of validation, exception event, and change control processes.
  • Documenting all activities in line with cGMP requirements.
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Performing cross training within the team and training of new team members.
  • Generation of validation protocols and final reports to cGMP standards.
  • QA support for validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various validation and qualification documents
  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
  • Coordinating activities to maximize the effectiveness of all of the team members.
  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns

Requirements

  • 3 years plus validation/Quality experience.
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the pharmaceutical / medical device industry
  • Strong communication (written and oral), presentation and troubleshooting skill required
  • Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.

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