Qualified Person


A biopharmaceutical company in East Cork requires a Qualified Person. The successful candidate will certify batches for sale or supply in compliance with regulations.


  • Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations.
  • Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
  • Attends and participates Event Review, Quality Systems Review and Site QP Meetings.
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
    Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis to enforce requirements and meet specifications.
  • May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
  • May assist or lead compliance audits as required.
  • May interface with regulatory agencies as required.
  • Interfaces with contract manufacturers to address documentation and compliance issues.

Qualifications & Experience:

  • Educational background min requirement QP Qualification; Product: SOD and or Sterile and or Biological and or Secondary Packaging.
  • Previous experience as a QP on a manufacturing license.
  • Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities.
  • Proven analytical and conceptual skills.
  • Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
  • Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
  • Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
  • Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.