Senior Quality Assurance Professional

5 hours ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000
Job Title: QA Senior Specialist Compliance

We are seeking an experienced Quality Assurance professional to join our team in Dublin. This is an exciting opportunity to work on a large-scale project, leveraging cutting-edge technology and developing current skills.

Main Responsibilities:

  • Review and Approve Quality Agreements: Ensure compliance with regulatory requirements and quality standards.
  • Release Incoming Materials: Facilitate the use of materials in manufacturing operations.
  • Support Supplier Qualification: Evaluate and approve new suppliers and materials.
  • Assess Supplier Change Notifications: Determine the impact on qualification status.
  • Support Material Certification and Direct Dispense Programs: Develop and implement certification processes.
  • Author QA-Related Procedures: Create, review, and approve procedures for quality assurance.
  • Support Operational Excellence (OpEx) Initiatives: Champion continuous quality improvement initiatives.
  • QA Review and Approval Activities: Assess and approve change controls, deviations/investigations, CAPAs, and other associated documentation.

Requirements:

  • Bachelor's Degree in Science or related field with at least 2 years' experience in Supplier Quality or related field in a Biologics or Pharmaceutical environment.
  • Clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
  • Detailed knowledge of Biologics Processing would be a distinct advantage.
  • Able to work independently as well as part of a team.
  • Excellent communication, presentation, time management, and organizational skills are essential.

This role offers the opportunity to work within a fast-paced, dynamic environment with a talented team. If you have a passion for quality assurance, please apply now.

Benefits

This role offers a chance to work with a talented team and contribute to the success of our organization.

We offer a competitive salary and benefits package.

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