Qualified Person Job 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.
Knowledge: 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.
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.
Specific Education