Job Description
Our Client, a leading manufacturer in the Pharmaceutical industry , is looking to hire a QA specialist on a 16 month contract. The position requires sound knowledge of quality assurance systems, methods, and procedures, as well as critical thinking and excellent communication skills. The candidate will need to exercise judgment within well-defined and established procedures. Responsibilities: Participating within inter-departmental and cross-functional teams to ensure quality objectives are met. Performing a variety of activities to ensure compliance with applicable cGxP regulatory requirements. This includes developing and implementing changes to Standard Operating Procedures and controlled documents. Maintaining the ongoing compliance of the Quality Management System. Drafting and maintaining quality policies and procedures to outline the expected quality standards and practices. Participating in developing Standard Operating Procedures and implement changes to controlled documents to meet quality objectives. Playing a key role in maintaining regulatory compliance and the integrity of the Quality Management System within the organization. Qualifications and Experience Prior experience in pharmaceutical industry (ideally within a QA role) 6 + years of experience within GMP environment related fields and a BS. 4 + years of relevant experience and an MS. Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems) Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards. Maintains and develops programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary. Provides guidance and technical knowledge to personnel. Good knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations. Demonstrates audit and investigation skills, and report writing skills. Demonstrates strong verbal, technical writing and interpersonal skills. Proficiency in Microsoft Office applications. Positive attitude. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Process orientated to achieve the business objective. KSGalway Gi Group Holdings Recruitment Limited group of companies includes Gi Recruitment Limited, Draefern Limited, Gi Group Recruitment Ltd, INTOO (UK) Limited, Marks Sattin (UK) Limited, TACK TMI UK Limited, Grafton Professional Staffing Limited, Encore Personnel Services, Gi Group Ireland Limited and Kelly Services (UK) Ltd. Gi Group Ireland Ltd are acting as an Employment Business in relation to this role. We are committed to protecting the privacy of all of our candidates and clients. If you choose to apply, your information will be processed in accordance with the Gi Group Privacy Statement. To view a copy and to help you understand how we collect, use and process your personal data please visit the Privacy page on our Gi Group website. Skills: Quality engineering pharmaceutical