Qualified Person

Summary:
A biopharmaceutical company based in Cork requires a Qualified Person.

Responsibilities:

• 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:

• Relevant degree and QP Qualification.
• 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.
• Proven analytical and conceptual skills.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates working knowledge with good proficiency in Microsoft Office applications.
• 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.