Validation Engineer Professional

2 days ago

Sligo, Sligo, Ireland beBeeAssurance Full time €60,000 - €80,000
Quality Assurance Specialist

As a Quality Assurance Specialist, you will be responsible for ensuring the site's validation program is properly developed and maintained. This involves working closely with various teams to ensure compliance with regulatory requirements and quality standards.

Job Description:

The primary focus of this role is to coordinate the development and maintenance of the site's validation program, as well as to ensure that AbbVie and external regulatory, quality, and compliance requirements are met.

This includes coordinating activities such as validation and quality assurance of site equipment, utilities, processes, and software in compliance with AbbVie policies, FDA, European cGMP, and GAMP standards.

You will also be responsible for generating/maintaining/executing the Site Validation Master Plan, Project Validation Plans, and schedules.

Additionally, you will generate validation protocols and final reports to cGMP standards, as well as investigation and implementation of corrective actions.

Furthermore, you will create/review/approve various quality documents and test data, manage validation, exception event, and change control processes, and maintain tracking of validation equipment if applicable.

Required Skills and Qualifications:
  • Qualification and/or degree in engineering or scientific discipline.
  • 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
  • 3 years plus of knowledge of cGMP and regulatory requirements relating to the medical device industry.
  • Strong communication (written and oral), presentation and troubleshooting skills required.

Benefits:

Key Responsibilities:

  1. Coordinate/direction and active participation in the validation and quality assurance of site equipment, utilities, processes, and software.
  2. Generation/maintenance/execution of the Site Validation Master Plan.
  3. Generation/maintenance/execution of Project Validation Plans and schedules.
  4. Generation of validation protocols and final reports to cGMP standards.
  5. Generation of validation investigations and implementation of corrective actions.
  6. Creation/review/approval of various quality documents and test data.
  7. Management of validation, exception event, and change control processes.
  8. Maintenance and tracking of validation equipment, if applicable.

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