Description Responsibilities General · Maintain knowledge in the current and relevant regulations and guidance in accordance with role demands and changes · Provide guidance and advice on regulatory requirements. · Support the execution of Quality Management System · Perform QA Review of Controlled Documents within the eQMS · Ensure accurate completion of timesheets on a weekly basis · Assist in the implementation of a positive quality culture within the quality team & operations Specific · Execute audits (including study & process audits/self-inspections) against agreed programme(s) and schedules. · Support Quality Incident investigations, OOS, Change Control and CAPA to completion · Liaise with clients and internal stakeholders in the preparation and execution of quality agreements. · Review/Audit CSV documentation. · Monitor the Quality Events mailbox · Review AS Methods, Deviations, SOPs · Occasional travel to Resolian Sandwich may be required · CAPA Assessment · Vendor Assessments and audits Skills, Education & Qualifications A Quality professional with good knowledge and understanding of the regulated environment, knowledge of the respective regulations and standards themselves, along with their application. Demonstrable audit skills that can be practicably applied to enable an independent auditing activity, both as an individual and as part of a team to ensure coverage for all relevant areas of the business. Participate in the operation of the Quality Management System and challenge processes and procedures to deliver a high quality QMS. Awareness of the company business, its needs, and how these align to regulatory expectations. A self-motivated individual who is able to make decisions based on factually derived evidence and show initiative in performing audits independently and as part of a team. Note: Respective regulations and standards may include, but are not limited to, GMP, GLP, GCP, Eudralex, FDA, ISO – the awareness and understanding around which may vary in accordance with dynamics of the role requirements, but must always be accurately reflected in training records.