QA Advisor/ Sr. QA Advisor in Fordham

Responsibilities

• 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
• Occasional travel to Resolian Sandwich may be required
• 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.