29 ott - Roma
Ergomed
Job Description
Job Description
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 GxP expertise.
Core responsibilities of the Senior Auditor are:
- Auditing
- Within area of their GxP 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
- Consultancies e.g. Client PV / QMS system gap analysis, SOP development, etc.
- Main QA contact for designated Clients and plans, conducts and reports on audits requested by Clients
- Quality as a Service
- Attend commercial meetings related to Quality as a Service
- Supports Clients with a wide variety of Quality as a Service activities, including
- Mock inspections
- Training
- Gap analysis
- Procedure drafting and revision
- Other
- 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