Job Description
A QP is required on an initial 12-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharma company. THE ROLE: 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 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 REQUIREMENTS: 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. 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 Desirable: 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. Please call Aisling OHagan-Yil today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices inCork,Shannon,Galway,Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: QMS RA Lean