Global Quality Assurance Auditor, Pharmacovigilance

Job Description Summary This role is responsible for providing QA auditing for the Pharmaceutical Diagnostics (PDx) business. This role will have a focus on auditing and Global Compliance support to the GMP manufacturing sites and Pharmacovigilance (PV) related functions. Suitable candidates should have experience in the Pharmaceutical industry. The role will perform audits on behalf of CQA with a focus on PV. In this role insights and industry trends are to be proactively shared within the organization to ensure continued compliance and early identification of areas for continuous improvement. This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within PV QA. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives. Job Description Roles and Responsibilities Support a program (plan, prepare and execute) of internal and external audits for QRA. Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity. Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits. Support regulatory inspections and customer audits as a functional QA subject matter expe