Job Description
Elusav Recruitment have an excellent opportunity with a leading global Pharma and Biopharma company who is seeking aAssociate Specialist, Quality Assurance in Carlow, Ireland. The Associate Specialist will be responsiblefor ensuring that the process for the manufacture of drug product at the company site is in compliance with cGMP and the associated regulatory requirements. Responsibilities: Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same. Support the development and implementation of improved quality reporting measures. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process. Work shift patterns in line with manufacturing operations to ensure Quality oversight as required. Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations. Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained. Provide training in all aspects of Quality Management Systems and all work is carried out in line with SOPs, training or other quality systems such as change controls where applicable. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Drive compliance with the company Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems. Requirements: Third Level Degree qualified in a Science/Technical or related discipline. Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site. GMP Audit experience in the pharmaceutical industry. Problem-solving / critical thinking ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends. Report, standards, policy writing skills required. Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights. Contact: If you would like to learn more about the vacancy, apply now, or contact Thaissa Torres on or . Skills: GMP Documentation QA