Quality Assurance Specialist

13 hours ago

Dublin, Dublin City, Ireland beBeeQuality Full time €70,000 - €90,000

Our organization is dedicated to creating a healthier world by empowering people at every stage of life.

The Role
  • We are seeking an experienced Quality Systems Specialist to develop and implement site quality systems, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.
  • This individual will provide QA support to ensure site inspection readiness.
  • The role requires collaboration with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality teams.
  • Responsibilities also include the operation of the site training system, including preparing and presenting relevant training material as required.
  • The candidate will support regulatory compliance, particularly in Dublin Respiratory reviews, and generation of supporting documents including API Declaration, Approved Product List, Approved Oversight List.
  • Staying up-to-date with new regulatory initiatives and guidance is essential.
  • The specialist must ensure compliance with relevant regulatory documents while driving improvements in product and process quality.
  • Additionally, this role involves supporting the implementation of our Continuous Improvement program by identifying, leading and implementing improvements.
  • Maintaining adherence to company and legislative Environment, Health and Safety Requirements is also crucial.

About This Position

  • We are looking for a candidate who possesses an effective combination of the following qualifications, skills and experiences:
  • A degree-level education with proven industry experience is necessary.
  • Familiarity with EU and US regulatory requirements is required.
  • Experience in designing and implementing quality systems or starting a business is advantageous.
  • Knowledge of inhalation dosage forms is beneficial.
  • High proficiency in Microsoft Office applications, including Word, Excel, PowerPoint and MS Project, is essential.
  • Proficiency in electronic systems/databases such as documentation, Trackwise and SAP is also necessary.
  • Strong team working and communication skills across functions and organization are required.
  • The ability to work flexibly in a changing environment, with good attention to detail and priority management, is essential.
  • Flexibility to learn new skills and take on new tasks and responsibilities is also required.
  • The ability to work under pressure to meet demanding schedules, as well as work independently, is important.

Benefits and Perks

  • Join a dynamic organization that values employee growth and development.
  • Work with a talented team dedicated to creating a healthier world.
  • Opportunities for professional growth and advancement.
  • A supportive and collaborative work environment.

Additional Information

  • This is a unique opportunity to join a forward-thinking organization that prioritizes innovation and excellence.
  • Apply today to take the first step towards a fulfilling career in quality assurance.

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