PV Auditor - Global Quality Assurance (QA) (m/f)

Job description

Job Description

We are looking for a
PV Auditor Global Quality Assurance (QA) (m/f)
(Project-No. 161870BR

• Conduct pharmacovigilance (PV) quality systems audits at Sandoz own sites/entities (e.g. country operations offices and development centers) and Third Party contractors or suppliers as lead or supportive auditor to assess all aspects of the operational business for compliance with PV legal and regulatory requirements, the Novartis Group Quality Manual, and other required policies
•Approve Corrective and Preventive Action Plans which are resultant from audit findings
•Evaluate and trend audit and Health Authority inspection findings using available information and electronic databases
•Develop, deliver and support training sessions on PV and auditing topics for internal and external audiences
•Assist in ensuring that Sandoz sites are prepared for Regulatory Agency Inspections through normal audit activities, “Mock Inspections”, training and other on-site support activities
•Serve as Subject Matter Expert on PV related compliance topics. Support the Quality Systems Program and other internal compliance initiatives

Desired profile

• Education: Graduate Degree in Pharmacy, Medicine or another related science; additional knowledge in Quality Assurance/Compliance and Auditing; MD desired
• Languages: English fluent in speaking and writing, 2nd language desirable
• Experience: 3-5 years experience in the pharmaceutical or biopharmaceutical industry in the area of PV or Clinical QA
• Prior auditing experience (PV or GCP) desirable
• Some PV knowledge required
• Availability for min. 50 % travel on regional / global basis