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Quality Assurance Specialist

3 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000
Job Opportunity

We are seeking a highly skilled professional to join our team as a Quality Assurance Specialist. This role will involve supporting the Qualified Person with batch certification, preparing and reviewing documentation packages, and liaising with colleagues to ensure timely disposition.

Duties and Responsibilities:

  • Support the Qualified Person with batch certification activities.
  • Prepare and review documentation packages for QP release in accordance with SOP requirements.
  • Liaise with quality and supply chain colleagues to ensure consistent meeting of disposition timelines.
  • Update controlled documents such as SOPs and forms as required.
  • Assist in new product introduction activities as necessary.
  • Provide training to new team members on quality procedures and processes.
  • Support site inspection readiness programs for corporate and regulatory inspections.
  • Identify opportunities for process improvements and make recommendations to enhance continuous improvement.
  • Participate in quality management system activities such as change control, self-inspections, and quality agreement updates.

Requirements:

  • A degree in science or engineering is essential, along with a minimum of 1-2 years' experience in pharmaceutical or biopharmaceutical industry.
  • Proficiency in data or electronic document management systems such as DCA, Trackwise, Infinity, and SAP.
  • Strong working knowledge of Microsoft Excel and PowerPoint.
  • Ability to work independently and as part of a team.
  • Good organizational skills and attention to detail.
  • Ability to handle multiple assignments and changing priorities.
  • Ability to learn and utilize computerized systems for daily task performance.
  • Ability to prioritize tasks and meet deadlines.

Benefits:

  • Competitive salary package including annual bonus and pension contribution.
  • Comprehensive benefits package including family health insurance and life assurance.
  • Access to on-site gym and 27 days annual leave.

About the Role:

This is an excellent opportunity to contribute to the fight against serious diseases while working in a dynamic and innovative environment that encourages excellence and innovation.

As a Quality Assurance Specialist, you will play a key role in ensuring the highest standards of quality are met in our operations.