PE Global are currently recruiting for a Contract Qualified Person (QP) for a client site in Cork 18 month initial contract Previous experience as a QP on a manufacturing license. Educational background min requirement: QP Qualification; Product: SOD and or Sterile and or Biological and or Secondary Packaging Qualified Person (QP) Essential Duties and Job Functions: 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, Experience and Skills: 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. 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. Behaviours Resilient profile with the ability to deliver in an ambiguous environment Ability to engage and manage multiple stakeholders to achieve the objective Curious with learning agility Operationally excellent Organised with systematic approach to prioritisation Process orientated to achieve the business objective Interested candidates should send their CV to or call Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: qualified person QP manufacturing licence