Senior QA Auditor

Medicine moves forward here. Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life's meaningful moments. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world. The science and analysis that guides our work is demanding. And this is where we excel. And every person has room to make a real difference to patients' lives. Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. The Senior Auditor, Quality Assurance role is a senior role that effectively manages and conducts internal and contracted audits for the Company and for Company's Clients. The role provides input into audit strategy and risk-based audit planning and leads process and complex audits, as well as providing QA consultancy activities within their area of Gx P expertise. Auditing Within area of their Gx P expertise, conduct audits initiated by the Company, or contracted by small to mid-size Clients, according to the agreed Audit Program including effective management of pre-audit activities. Audit types may include: Audits of Company Partners and Vendors/Service Providers Internal System Audits Study audits (e.g. of study files, investigational sites) Audits of Third Parties on behalf of Clients (e.g. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits).
Reviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client procedures Main QA contact for designated Clients and plans, conducts and reports on audits requested by Clients Attend commercial meetings related to Quality as a Service Supports Clients with a wide variety of Quality as a Service activities, including Training Supports audits and inspections of the Company performed by Clients/third parties and regulatory authorities Works with the Quality leadership to develop and train Auditors and other quality employees Assists in the development of strategic internal audit program Maintain an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participate in knowledge-sharing and learning process to ensure personal and team continuous learning and development Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the Company and/or Client as per operational needs Qualifications Bachelor's degree in a scientific discipline required; Master's degree preferred, or equivalent relevant industry experience. Experience Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including strong understanding of GVP & GCP related Quality Management and Assurance, with previous experience of GVP and GCP auditing experience in an Audit Lead role. Fluent in English (written and spoken); additional/ local languages a plus, but not required Additional Information When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. Our values are how we work, not words on a wall. Integrity and trust: we do the right thing, especially when it is hard. Drive and passion: we care about the outcome, because someone is waiting on it. Collaborative partnerships: we go further by going together. By clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply