Senior Quality Assurance Professional

2 days ago

Cork, Cork, Ireland beBeeQualification Full time €80,000 - €120,000
Quality Assurance Specialist

 

A quality assurance specialist is required to ensure compliance with quality standards in the activities related to qualification and validation of systems, equipment, and facilities throughout their lifecycle.

 

  • Key responsibilities include:
  1. Ensuring cGMP compliance in the qualification and validation of systems, equipment, and facilities.
  2. Coaching and training sites' quality and operational areas on continuous improvement standards.
  3. Promoting a culture of quality and validation within the organization.
  4. Reviewing and proposing changes to corporate procedures that regulate qualification and validation activities.
  5. Guaranteeing the fulfillment of applicable quality and regulation requirements in all projects.
  6. Implementing risk-based approaches in qualification and validation-related activities.
  7. Providing guidance on qualification and validation subjects to clients and health authorities.
  8. Participating in conceptual, basic, and detailed design reviews for projects.
  9. Planning and establishing qualification and validation requirements for each project.
  10. Establishing qualification activities of new or changed systems and/or facilities within the change control process.
  11. Preparing and approving validation management plans (VMPs) for projects.
  12. Approving qualification and validation protocols and final VMP reports.
  13. Reviewing reports and participating in internal or external audits and inspections.
  14. Managing complex projects with significant business impact.
  15. Deciding on quality and timely matters based on multiple sources of data.
  16. Managing risk and uncertainty and anticipating roadblocks.
  17. Carrying out assigned tasks in a safe manner according to instructions and environmental, health & safety rules/procedures.
  18. Implementing lean tools and other relevant tools for area objectives.

 

The ideal candidate will have a university degree in chemistry, chemical engineering, mechanical engineering, or a similar scientific field. They must have typically 5-8 years of relevant experience in quality and qualification/validation in an industry environment.

 

They should have advanced knowledge of quality, engineering, cGMP, ICH, and ISO guidelines, risk assessment applied to qualification and validation, and lean 6-sigma. They must be able to solve complex problems.

 

The candidate must be computer literate with good working knowledge of the MS Office package. Fluency in English is also required.

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