The role: PE Global is currently recruiting for a Qualified Person on behalf of a leading pharmaceutical company in Cork. This is an initial 12 month contract role.
Description: Quality Assurance delivers on commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
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. Release of Investigational medicinal Products in accordance with the requirements of Annex 13. Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations). Attends and participates in 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. Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Education and Experience: 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. Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use. Some years of relevant experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS. Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or Failure Mode Effects Analysis (FMEA)) is beneficial. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial. Interested candidates should submit an updated CV.
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